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Table 1 List of products with conditional appraisalsa and/or PAMsb

From: Comparison of post-authorisation measures from regulatory authorities with additional evidence requirements from the HTA body in Germany – are additional data requirements by the Federal Joint Committee justified?

Product

Brand name

Indication

Conditional appraisalsd

PAMse

y/n

Time frame (years)

Number

Time frame (years)

Aclidinium bromide

Eklira Genuair/Bretaris Genuair

COPD

No

-

1

n.a.

Afatinib

Giotrif

Non-small-cell lung carcinoma

Yes

1

0

-

Afliberceptf

Zaltrap

Metastatic colorectal cancer

No

-

1

4

Afliberceptf

Eylea

Age-related macular degeneration

No

-

1

5

Aliskiren/amlopidine

Rasilamlo

Essential hypertension

No

-

2

1; n.a.

Axitinib

Inlyta

Renal cell carcinoma

Yes

4

0

-

Belatacept

Nulojix

Renal transplantation

Yes

3

0

-

Belimumab

Benlysta

Systemic lupus erythematodes

No

-

3

1.5; 8.5; 11.5

Boceprevir

Victrelis

Chronic hepatitis C

No

-

1

4.5

Bosutinibg,c

Bosulif

Chronic myeloid leukaemia

Yes

5

2

1; 5.5

Brentuximab vedoting,c

Adcetris

Hodgkin lymphoma, anaplastic large-cell lymphoma

No

-

4

Annually; 3.5; 3.5; 6

Crizotinibc

Xalkori

Non-small-cell lung carcinoma

Yes

2

2

1.5; 3.5

Dabrafenib

Tafinlar

Melanoma

Yes

3.5

0

-

Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil

Stribild

HIV infection

No

-

1

0.5

Emtricitabine/rilpivirine/tenofovir disoproxilh

Eviplera

HIV infection

No

-

2

1; 2

Eribulin

Halaven

Breast cancer

Yes

2

0

-

Extract of Cannabis sativa

Sativex

Multiple sclerosis

Yes

3

No centralised procedure

Fampridinec

Fampyra

Multiple sclerosis

No

-

1

5.5

Fidaxomicin

Dificlir

Infection with clostridium

No

-

2

1.5; 1.5

Fingolimod

Gilenya

Multiple sclerosis

Yes

3

1

9.5

Fluticasone furoate/vilanterol trifenatate

Relvar Ellipta

Asthma, COPD

No

-

2

2; 2.5

Indacaterol/glycopyrronium

Ultibro Breezhaler, Xoterna Breezhaler

COPD

No

-

1

5

Ipilimumabi

Yervoy

Melanoma (pre-treated)

Yes

5

1

6

Ipilimumab (new indication)i

Yervoy

Melanoma (treatment-naïve)

Yes

3.5

1

6

Ivacaftorg

Kalydeco

Cystic fibrosis

No

-

2

3.5; 5.5

Lixisenatide

Lyxumia

Diabetes mellitus type 2

No

-

1

1.5

Lomitapidec

Lojuxta

Hypercholesterolaemia

Yes

1

2

Annually; 6.5

Ocriplasmin

Jetrea

Vitreomacular traction

Yes

5

0

-

Pertuzumab

Perjeta

Breast cancer

Yes

5

2

3.5; 4.5

Pirfenidoneg

Esbriet

Idiopathic pulmonary fibrosis

No

-

1

6.5

Pixantronec

Pixuvri

Non-Hodgkin lymphoma

No

-

1

3

Pomalidomideg

Imnovid

Multiple myeloma

No

-

2

1; 7

Ponatinibg

Iclusig

Lymphoblastic leukaemia, myeloid leukaemia

Yes

1

0

-

Regorafenib

Stivarga

Colorectal cancer

Yes

1.5

5

0.2; 0.2; 1; 2; 7.5

Rilpivirineh

Edurant

HIV infection

No

-

2

1; 2

Ruxolitinibg

Jakavi

Chronic myeloproliferative disorders

No

-

2

Annually; 1

Saxagliptin/metformin

Komboglyze

Diabetes mellitus type 2

Yes

2

0

-

Tafamidis meglumineg,c

Vyndaqel

Amyloidosis

No

-

1

annually

Ticagrelor

Brilique

Acute coronary syndrome

No

-

1

2.5

Trastuzumab emtansine

Kadcyla

Breast cancer

No

-

3

1; 3; 3.5

Vandetanibj,c

Caprelsa

Thyroid neoplasms

Yes

3

2

2; 4

Vemurafenib

Zelboraf

Melanoma

Yes

1

1

2

Vismodegibc

Erivedge

Basal cell carcinoma

Yes

2

2

1; 2

  1. COPD chronic obstructive pulmonary disease, n.a. not available, EPAR European Public Assessment Report, PAM post-authorisation measure
  2. a N = 19 (20 appraisals);
  3. b N = 33 (34 EPARs);
  4. cindicates conditional marketing authorisation (bosutinib, brentuximab vedotin, crizotinib, fampridine, pixantrone, vandetanib and vismodegib) or marketing authorisation under exceptional circumstances (lomitapide, tafamidis meglumine)
  5. dConditional appraisals are issued with a single time frame
  6. eMore than one PAM per product is possible; time frames are issued per PAM
  7. fAflibercept is marketed as Zaltrap for colorectal cancer and as Eylea for age-related macular degeneration (AMD) and central retinal vein occlusion (CRVO). Therefore, 3 benefit assessments (one for each indication) and 2 EPARs (for Eylea and Zaltrap) are available for aflibercept. The PAM given in the Eylea EPAR refers to AMD; Eylea for CRVO was therefore omitted from the table
  8. gMedicinal products with orphan status
  9. hFor emtricitabine/rilpivirine/tenofovir disoproxil and rilpivirine, the same PAM was requested and was counted twice
  10. iIpilimumab received a license expansion that resulted in an EPAR variation and a second benefit assessment. It had one PAM that was considered applicable to both indications and was therefore counted twice
  11. jIn case of no additional benefit due to missing data, the manufacturer can apply for re-assessment and subsequently submit the missing data. This was done for vandetanib, and only the second assessment (with conditional appraisal) was included
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Health Economics Review

ISSN: 2191-1991

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