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PRMA Insights Focus:Pricing and Reimbursement Success in Germany under AMNOG

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This PRMA Insights Focus report provides in-depth analysis of the evidentiary and methodological issues of benefit assessment and price negotiation in Germany, and highlights key success factors to improve the likelihood of a favorable assessment to support premium pricing, impacting market access in Germany and beyond.

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Market access in Germany has become significantly more challenging since the AMNOG legislation was introduced. Even though the outcome of benefit assessment is a key driver of price negotiations, manufacturers have not always prepared dossiers adequately, compromising the outcome of the assessment and subsequent price that is agreed. In some cases, manufacturers have withdrawn from the German market in the face of substantial rebates. Lower prices in Germany will have a ripple effect across Europe and beyond, particularly in countries that use reference pricing, with implications for strategy and launch sequence.

This PRMA Insights Focus report provides in-depth analysis and understanding of the evidentiary requirements and benefit assessment process, and sets out practical recommendations and key success factors for manufacturers to ensure adequate preparation and likelihood of success.

Market access success

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IntroductionThe benefit assessment process that was introduced as part of the AMNOG legislation in 2011 has presented manufacturers with many new market access challenges. The methodological and evidentiary requirements are stringent, and preparation of the dossier is a time-consuming and expensive task: our experts liken it to preparing the EMA submission dossier, at a likely cost of €300,000–600,000 for dossiers of 400–600 pages

and up to €1 mn for a large dossier.

Analysis of the first 3 years of benefit assessment indicates that many manufacturers have not clearly understood – or met – the requirements in terms of the appropriate comparator, patient subgroups, acceptable endpoints, and methodology. Of 62 benefit assessments finalized to date, considering 113 subgroups, a resolution of “no additional benefit proven” was returned on 71 (63%); however, this was for technical reasons in the majority of cases: the dossier was incomplete in 23 (32%), the evidence was considered inappropriate by the G-BA in 27 (38%), and the appropriate comparator was not considered in 14 (20%). Clearly this has major implications for pricing, given that the G-BA’s decision on the extent of additional benefit relative to the appropriate comparator is a key factor in the pricing negotiation – and a poor benefit assessment result will severely compromise the final reimbursed price that can be achieved. Indeed, manufacturers have seen some substantial cuts in price.Lower prices in Germany will have a ripple effect across Europe and beyond, particularly in countries that reference price Germany. This has significant implications for strategic decisions about launch sequencing – whereas Germany has long been considered a key market in which to launch early, this may no longer be the case.


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Key factsA decision of “no additional benefit proven” was returned for 63% of the 113 subgroups considered in 62 benefit assessments to date.

However, the decision of “no additional benefit proven” was for technical reasons in 90% of cases, not because the drug did not provide additional benefit.

Key Success FactorCrucial factors and practical

information that significantly increase the chances of a successful

benefit assessment and therefore market access are highlighted.

Case StudyCase studies based on individual

benefit assessments are used throughout the report to

illustrate key points.

PRMA Strategic InsightsDeveloped by our in-house experts,

PRMA Strategic Insights provide critical advice to manufacturers in planning their market access

strategy.

This PRMA Insights Focus report provides in-depth analysis and understanding of the evidentiary requirements and benefit assessment process, and sets out practical recommendations and key

success factors for manufacturers to ensure adequate preparation and likelihood of success.

Reasons for no additional benefit provenBenefit assessment results

Appropriate comparator not considered

Evidence inappropriate

Evidence incomplete

No benefit shown

Less 1%

Significant

Not quantifiable

Marginal

Not proven

20%

32%

38%

9%

20%

7%63%

10%

Based on 113 subgroups in 62 benefit assessments completed to 31 October 2013

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Not all manufacturers have communicated with the G-BA to discuss the technical issues and challenges around preparation of the benefit dossier, or earlier to discuss the clinical trial.

What are the key aspects

that determine success or

failure of pricing negotiations?

Success will be determined by thorough preparations, the additional benefit demonstrated, prices in 15 European reference countries, the

prices of the comparators, and, importantly, negotiation skills.

Section 6.3(page 121)

Example key issuesBenefit assessment

• How will an NCE entering the German market be assessed?

• Are there any circumstances in which manufacturers can claim exemption from benefit assessment?

• What are the processes for orphan drugs? How do these differ from those for other NCEs?

• What information needs to be included in the benefit dossier?

• How are surrogate endpoints considered in the benefit assessment process?

• What can be done if the pivotal trial comparator is not the appropriate comparator defined by the G-BA?

• Will indirect treatment comparison be successful?

• How should manufacturers prepare for subgroup analysis by IQWiG and the G-BA?

Pricing

• What can be achieved through arbitration? Is it still worth entering the German market with a low benefit assessment rating?

• Is it always a disadvantage to be included in a reference price group?

Strategy

• Can a profitable price still be achieved in Germany?

• How will the price achieved in Germany affect prices elsewhere?

• Is Germany still an optimal early market for launch?

Consultation with G-BA prior to dossier submission

Appropriate comparator not considered

Advice sought

Reassessment No/incomplete dossier

Orphan drug

76%

Based on 62 submissions completed as at 31 October 2013

Other 5%3%

6%

10%

The FAQ section provides a quick reference source of commonly asked questions, focusing on misunderstandings

that our experts frequently encounter.

Question Key points Further reading

Case study


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Case studies of the following are included:

• Adcetris

• Caprelsa

• Eliquis, VTE

• Eliquis, stroke

• Elvanse

• Esbriet

• Fampyra

• Fycompa

• Gilenya

• Halaven

• Incivo

• Inlyta

• Jetrea

• Perjeta

• Rapiscan

• Trajenta

• Trobalt

• Vyndaqel

• Xalkori

• Yellox

• Zaltrap

• Zelboraf

• Zytiga

Drug Perjeta (pertuzumab, Roche)

Indica�on (EMA)Adults with HER2-posi�ve metasta�c or locally recurrent unresectable breast cancer who have not received previous an�-HER2 therapy or chemotherapy for metasta�c disease

General indica�on Breast cancer, in combina�on with Hercep�n and docetaxel

Date of resolu�on 1 October 2013

Assessment type New chemical en�ty

Rebate nego�ated Not published as at 31 Oct 2013

NotesPFS was not considered to be a pa�ent-relevant endpoint but was accepted to support OS as a pa�ent-relevant endpoint

HRQL data were not considered because they were based on a non-validated version of the FACT-B, and were defined post hoc

Key learnings

The appropriate comparator must be used according to German clinical prac�ce

PFS is not always accepted as a pa�ent-relevant endpoint; early discussion with the G-BA is recommended

HRQL data must be generated from validated ques�onnnaires

G-BA resolu�on

a Hint of considerable addi�onal benefit

b No addi�onal benefit proven (no data provided)

No addi�onal benefit proven (popula�on was not treated according to standard protocols in Germany)

Appropriate comparator defined by G-BA Radia�on therapy

Subgroups assessed by G-BA

HER2-posi�ve, locally recurrent, unresectable breast cancer

Scenario: endpoints were not considered pa�ent relevant

b non-visceral metastasis

Hercep�n + a taxane (paclitaxel, docetaxel)

HER2-posi�ve mBC witha visceralmetastasis

4.3.2 Multiple possible appropriate comparators4.3.3 Appropriate comparators and subgroups4.3.4 Changes to the medical standard

4.4 Indirect treatment comparisons4.4.1 Methodology4.4.2 Certainty of additional benefit based on indirect treatment comparison4.4.3 Success of indirect treatment comparisons to date4.4.4 Orphan drugs

4.5 Retrospective (historical) comparisons4.6 Endpoints

4.6.1 Patient relevance of endpoints4.6.2 Consideration of endpoints in benefit assessment4.6.3 Endpoints in oncology4.6.4 Use of surrogate endpoints4.6.5 Validation of surrogate endpoints

4.7 Incomplete submissions4.7.1 Data missing from the evidence base4.7.2 Data not submitted4.7.3 Non-existent data4.7.4 Data still in development at the time of submission

4.8 Submission of real-world data4.9 Requirements for economic data5 Benefit assessment for “special cases”5.1 Drugs not expected to cost the SHI funds more than €1 mn

in any 12 month period5.2 Orphan drugs

5.2.1 Orphan drugs expected to cost the SHI funds less than €50 mn in any 12 month period5.2.2 Orphan drugs expected to cost the SHI funds more than €50 mn in any 12 month period5.2.3 Debate over the €50 mn threshold5.2.4 Completed benefit assessments of orphan drugs

5.3 NCEs with a reference-priced appropriate comparator5.4 Pediatric drugs5.5 Benefit assessment of already-marketed drugs

5.5.1 Benefit assessment of the gliptins6 Pricing6.1 Role of the GKV-Spitzenverband6.2 Factors that determine the pricing process6.3 Price negotiation

6.3.1 Basis for price setting6.3.2 Price referencing6.3.3 Cost data6.3.4 Consideration of subgroups6.3.5 The negotiation meetings6.3.6 Opting out of price negotiation

6.4 Arbitration6.4.1 Restricted right to appeal

6.5 Individual contracting with the SHI funds6.6 Reference price groups6.7 Insight into the first negotiated prices7 The Impact of the AMNOG legislation in Germany and

beyond7.1 Impact on reimbursed prices in Germany7.2 Impact on reimbursed prices in Europe7.3 Long-term impact on drug availability in Germany8 Summary of benefit assessments to date and case studies

Executive summaryFrequently asked questions about benefit assessment1 Overview of P&R in Germany1.1 Statutory health insurance1.2 Key stakeholders1.3 Overview of pricing and reimbursement1.4 Drug expenditure controls

1.4.1 Introduction of the AMNOG legislation and benefit assessment1.4.2 Budget restrictions1.4.3 Reference pricing1.4.4 Individual contracting with SHI funds

2 The process of benefit assessment2.1 The aims of the AMNOG legislation2.2 Overview of the assessment process and timelines2.3 Development and submission of the benefit dossier2.4 Content of the benefit dossier

2.4.1 Eligible patient population2.4.2 Cost of therapy2.4.3 Module 5 (supporting evidence)2.4.4 Confidentiality2.4.5 Benefit dossiers for potentially reference-priced drugs

2.5 Determination of additional benefit: a three-step process2.5.1 The IQWiG evaluative assessment report2.5.2 Hearing procedure2.5.3 The G-BA’s declaratory benefit assessment – the resolution

2.6 Consultation with the G-BA2.6.1 Process2.6.2 Consultation during preparation of the benefit assessment2.6.3 Early consultation2.6.4 Outcomes of consultations to date

2.7 Resources required to develop and submit a benefit dossier3 Assessment of additional benefit3.1 The concept of additional benefit3.2 Methodological considerations

3.2.1 Evaluation of benefit versus harm3.2.2 Categories of additional benefit3.2.3 Certainty of additional benefit3.2.4 Application of the categories3.2.5 Expiry of resolutions in the event of uncertainty

3.3 Application with new data3.4 Analysis of benefit assessments to date

3.4.1 Overview3.4.2 Outcomes of no additional benefit proven3.4.3 Incomplete or inappropriate evidence3.4.4 Overruling of IQWiG recommendations by the G-BA

4 Methodological challenges4.1 IQWiG methodological guidance4.2 Patient populations and subgroups

4.2.1 Relevance of the trial population4.2.2 Differences between the trial and licensed population4.2.3 Subgroup analysis4.2.4 Relevance of the appropriate comparator to subgroups4.2.5 Statistical implications of subgroup analysis

4.3 The appropriate comparator4.3.1 Selection of the appropriate comparator

Table of contents

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Drug Perjeta (pertuzumab, Roche)

Indica�on (EMA)Adults with HER2-posi�ve metasta�c or locally recurrent unresectable breast cancer who have not received previous an�-HER2 therapy or chemotherapy for metasta�c disease

General indica�on Breast cancer, in combina�on with Hercep�n and docetaxel

Date of resolu�on 1 October 2013

Assessment type New chemical en�ty

Rebate nego�ated Not published as at 31 Oct 2013

NotesPFS was not considered to be a pa�ent-relevant endpoint but was accepted to support OS as a pa�ent-relevant endpoint

HRQL data were not considered because they were based on a non-validated version of the FACT-B, and were defined post hoc

Key learnings

The appropriate comparator must be used according to German clinical prac�ce

PFS is not always accepted as a pa�ent-relevant endpoint; early discussion with the G-BA is recommended

HRQL data must be generated from validated ques�onnnaires

G-BA resolu�on

a Hint of considerable addi�onal benefit

b No addi�onal benefit proven (no data provided)

No addi�onal benefit proven (popula�on was not treated according to standard protocols in Germany)

Appropriate comparator defined by G-BA Radia�on therapy

Subgroups assessed by G-BA

HER2-posi�ve, locally recurrent, unresectable breast cancer

Scenario: endpoints were not considered pa�ent relevant

b non-visceral metastasis

Hercep�n + a taxane (paclitaxel, docetaxel)

HER2-posi�ve mBC witha visceralmetastasis


6

Dr Helen BarhamHelen has led content development of multiple PRMA Insights titles, working closely with authors and contributors. She has broad knowledge of market access and P&R, combined with expertise in a wide range of therapy areas and more than 15 years’ experience in medical publishing. Helen has a PhD in Pharmacology from the University of Sheffield and conducted postdoctoral research in oncology at the former MRC Radiobiology Unit near Oxford.

David Sykes, Founding PartnerDavid has more than 15 years’ experience in P&R, market access, and health outcomes and has held senior leadership roles at Lilly and Johnson & Johnson. He has developed European and global P&R and market access programs to quantify, capture, and communicate product value. As PRMA Consulting’s founding partner, David provides leadership and strategic input around the complex issues that manufacturers face in bringing high-value innovative products to market across a broad range of therapy areas, particularly oncology and autoimmune disease.

Dr Casey QuinnCasey has 10 years’ experience in health economics and outcomes research, including economic evaluation, decision analysis, econometrics, and modeling methodologies, and in-depth understanding of the technical and evidentiary for HTA submissions in all the major markets. Casey leads a strong team of HEOR consultants and analysts providing evidence generation across economic modeling and evidence synthesis. Casey has a PhD in Health Economics from the University of York, and has taught economics, health economics, and statistics at universities in Australia, the UK, and the US.

Author profilesThe report has been written by AMNOG experts Monika Behrens and Rachel Bosshard, supported by PRMA Consulting’s extensive cross-functional expertise in developing market access strategies.

Monika BehrensBased in Germany, Monika has more than 15 years’ experience in the pharmaceutical industry and statutory health insurance in Germany. Before joining PRMA Consulting, she was responsible for market access strategy at GlaxoSmithKline in Germany, the UK, and Europe for a broad range of disease areas, including oncology/hematology, neurology, urology, and vaccines. Monika has an in-depth knowledge of the German healthcare system, particularly the AMNOG legislation, through regular attendance at workshops and training seminars, and through practical experience. She holds an MSc in Health Economics from the University of York and is a member of the DGGÖ, bdvb, and ISPOR.

Dr Rachel BosshardRachel has experience across a broad range of consultancy work, including systematic literature reviews, HTA reviews, PRO strategies, and development of the GHE strategy for an orphan drug. She also has in-depth knowledge and understanding of the P&R system in Germany and of benefit assessment and AMNOG in particular through practical experience and regular attendance at workshops and seminars. Rachel holds a PhD in Clinical Medicine Research from Imperial College London and an MSc in Natural Sciences from the Swiss Federal Institute of Technology, and has more than 5 years’ research experience in oncology and microbiology, gained in academia and the pharmaceutical industry.

The report has also been reviewed and validated by an academic with 15 years’ experience in industry and consulting, specializing in healthcare and market access, and the directors and heads of market access of the German affiliates of two top-10 pharma companies, each with more than 15 years’ industry experience.

Sample pages

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This report is licensed to FORENAME SURNAME of COMPANY; it may not be reproduced or disseminated outside of the organization.

66

PRMA Insights Focus: Pricing and Reimbursement Success in Germany under AMNOG3 Assessment of additional benefit

Figure 3.3 summarizes the outcomes for all benefit assessments completed to 31 October 2013. Since the introduction of benefit assessment, the G-BA has not assigned a resolution of major additional benefit to any drug. In its evaluative assessment of Jetrea in the treatment of vitreomacular traction (VMT), IQWiG recommended assignment major additional benefit for one patient subgroup (those with mild visual impairment); however, the G-BA did not agree, and assigned a resolution of significant additional benefit.

At the opposite end of the possible outcomes, the G-BA considered only one drug (Halaven) to have shown less benefit than the appropriate comparator, and that was in only one subgroup of patients, and reflected the safety profile of the drug. Table 3.6 gives examples of the breadth of resolutions published to date.

Jetrea p. 161

Marginal

Non-quantifiable

Significant

Less1%

Not proven7%

Figure 3.3 Resolutions for completed benefit assessments: extent of additional benefit

© PRMA Consulting 2014

63%

9%

20%

A resolution of “major” additional benefit has not been returned for any productBased on 113 subgroups in 62 benefit assessments completed at 31 October 2013

Halaven p. 158

Figure 3.2 Summary of benefit assessments completed up to 31 October 2013

a10 for orphan drugsbThe extent of additional benefit was less than for the appropriate comparator in one subgroupcPercentages refer to the proportion of cases for which no additional benefit was proven as a result of insufficient evidence (but not because the drug showed no benefit)


Additional benefit determined in

42 subgroups (37%)b

Evidence not sufficient;additional benefit

not proven in64 subgroups (57%)

Evidence available; additional benefit

not proven in 7 subgroups (6%)

Appropriate comparator not

considered: 14 (22%)c

Data inappropriate: 27 (42%)c

Data incomplete: 23 (36%)c

3 exceptions (<€1 mn) 1 termination 15 ongoing

81 dossiers submitted

62 benefit assessments completed,a

corresponding to 113 subgroups

Contents Fit page Fit width

This report is licensed to FORENAME SURNAME of COMPANY; it may not be reproduced or disseminated outside of the organization.119

PRMA Insights Focus: Pricing and Reimbursement Success in Germany under AMNOGPricing 6

The reimbursed price of the product at launch is determined by the manufacturer, and applies for a maximum of 1 year until the benefit assessment and price negotiation are complete. The outcome of the benefit assessment is a key determinant of the process by which the price is determined: through negotiation with the GKV-Spitzenverband, or inclusion in a reference price group, and also of the likely final price point (presented in the Lauer Taxe as a rebate). Figure 6.1 provides an overview of the benefit assessment and price negotiation options. Note that the majority of NCEs are reimbursed from launch; benefit assessment does not affect reimbursement.

6.1 Role of the GKV-SpitzenverbandThe GKV-Spitzenverband has full jurisdiction for the setting of reference prices (Section 6.6, page 125) and negotiating prices with manufacturers – the G-BA is not involved in pricing activities. The GKV-Spitzenverband is also a mandatory member of the G-BA, and members are involved in various G-BA committees relating to legislative issues. As shown in Figure 6.2, the GKV-Spitzenverband is involved in all steps of the benefit assessment process, assessing the benefit dossier and the additional benefit, and leading the price negotiations. It has been argued that this widespread role violates the principle of separation of powers and it has prompted frequent discussions about potential conflicts of interests and the fairness of the process, particularly in terms of its neutrality.

YesNo

Yes No

Optional

On request (after arbitration)

Optional

Figure 6.1 Options for the benefit assessment process and price negotiation


Individual contracts: manufacturer and

SHI funds(§ 130c SGB V)

Framework for pack sizes, data collection etc.: pharmaceutical

association and GKV-Spitzenverband

(§ 131 SGB V)

Additionalbenefit

Cost–benefit assessment

(§ 35b SGB V)

Price negotiation: manufacturer and

GKV-Spitzenverband(§ 130b SGB V)

Reference price group

Benefit assessment

(§ 35a SGB V)

Reference price regulations(§ 35 SGB V)

Algorithm for reference price

(GKV-Spitzenverband)

Selection ofappropriatecomparator

SGB V, Sozialgesetzbuch 5. Buch (Social Code Book V); SHI, statutory health insurance

PRMA Strategic Insight

As the GKV-Spitzenverband is a mandatory member of the G-BA, representatives of the GKV-Spitzenverband involved in pricing are likely to be members of the G-BA decision-making boards as well. Therefore, the price negotiations should be considered as a continuation of the discussion held during the hearing procedure.


This report is licensed to FORENAME SURNAME of COMPANY; it may not be reproduced or disseminated outside of the organization.147

PRMA Insights Focus: Pricing and Reimbursement Success in Germany under AMNOGSummary of benefit assessments to date and case studies 8

Table 8.2 Index of case studies (alphabetical order by brand name)

Product Therapy area Date of resolution

Scenario presented in case study Page

Adcetris (brentuximab vedotin)

Hodgkin’s lymphoma, anaplastic large cell lymphoma

16 May 2013 Orphan drug; historical control study (single-arm trial); endpoints were not considered patient relevant

149

Caprelsa (vandetanib)

Thyroid cancer 6 June 2012; re-assessed 5 Sept 2013

Resolution of “no additional benefit proven” because the trial population was larger than the licensed population and the validity of the surrogate endpoints was questioned

150

Eliquis (apixaban) Prophylaxis of venous thromboembolism after hip or knee replacement

7 June 2012 Resolution of “no additional benefit proven” in one subgroup on the basis of the trial data, not because of a technical issue with the dossier

151

Prophylaxis of stroke 20 June 2013 First drug to go through benefit assessment for a second indication

152

Elvanse (lisdexamfetamine dimesylate)

Attention deficit hyperactivity disorder

14 Nov 2013 One of the first drugs with a pediatric indication to go through benefit assessment

153

Esbriet (pirfenidone)

Idiopathic pulmonary fibrosis

15 Mar 2012 First orphan drug to go through benefit assessment; the only orphan drug to be evaluated by IQWiG

154

Fampyra (fampridine)

Multiple sclerosis 2 Aug 2012 Resolution of “no additional benefit proven” because the appropriate comparator determined by the G-BA was not used

155

Fycompa (perampanel)

Epilepsy 7 Mar 2013 Resolution of “no additional benefit proven” because the appropriate comparator determined by the G-BA was not used

156

Gilenya (fingolimod)

Multiple sclerosis 29 Mar 2012 “Hint of marginal additional benefit” in only one of three subgroups defined by the G-BA

157

Halaven (eribulin) Advanced/metastatic breast cancer

19 Apr 2012 Resolution of less benefit than the appropriate comparator, reflecting potentially greater harm; resolution restricted pending safety and HRQL data

158

Incivo (telaprevir) Chronic HCV-1 infection

29 Mar 2012 Detailed subgroup analysis by IQWiG was overruled by the G-BA

159

Inlyta (axitinib) Renal cell carcinoma 21 Mar 2013 Resolution of “no additional benefit proven” because the data were considered inappropriate

160

Jetrea (ocriplasmin)

Vitreomacular traction 17 Oct 2013 The only drug for which IQWiG has recommended major additional benefit, although the G-BA resolution was hint of considerable additional benefit; the G-BA considered a broader population than the label indication

161

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PRMA Insights Focus: Pricing and Reimbursement Success in Germany under AMNOG7 The Impact of the AMNOG legislation in Germany and beyond

importer, Kohlpharma, subsequently re-introduced Trobalt and negotiated the price with the GKV-Spitzenverband and arbitration board; however, the rebate on the freely chosen manufacturer’s price was over 90% and, as a result, the drug was completely withdrawn from the German market.

It should be borne in mind that if a manufacturer withdraws a drug from the market, an importer can negotiate a price with the GKV-Spitzenverband based on the dossier submitted by the original manufacturer. Negotiation of an “unfavorable” price by an importer may have broad repercussions, influencing the price that the manufacturer can achieve in other countries that reference Germany (see Figure 7.1).

Price relative to the lowest European price (%)

Figure 7.3 Comparison of reimbursed prices in Germany with the lowest EU list prices for drugs launched in the 15 EU reference countries

Note that prices may be subject to further confidential discountsCase studies are available for the products shown in bold (pages 147–172)Source: adapted from Cassel, 2013


Marginal

Significant

17.1

4.2

3.5

2.0

30.2

27.2

26.5

0.0

2.7

8.0

Not quantifiable

Kalydeco

Brilique

Benlysta

Zytiga

Yervoy

Zelboraf

Edurant

Eviplera

Eliquis

Nulojix

Signifor

Vyndaqel

Halaven

Jevtana

Jakavi

Gilenya

Inlyta

Sativex

Incivo

Victrelis

Teysuno

Yellox

Trobalt

Esbriet

Eklira

Rapiscan

Fampyra

None

40100 80 60 40 20 0 20

Lower Higher

22.4

45.0

1.8

3.5

6.3

9.1

15.7

18.5

24.2

62.8

10.6

13.8

16.7

39.1

47.7

65.6

78.3


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