Table 1 Types of HTA recommendations for orphan drugs issued in the analyzed period
From: The correlation between HTA recommendations and reimbursement status of orphan drugs in Europe
Country | Types of positive recommendations issued | Types of partially positive / conditional recommendations issued | Types of negative recommendations issued |
|---|---|---|---|
Germany | - Major additional clinical benefit - Significant additional clinical benefit - Marginal additional clinical benefit | - Additional clinical benefit not quantifiable | - No additional clinical benefit - Lower additional clinical benefit |
France | - Major improvement of medical benefit - Important improvement of medical benefit - Moderate improvement of medical benefit | - Minor improvement of medical benefit | - No improvement of medical benefit |
Netherlands | - Inclusion on List 1Bb – non-interchangeable drug with added therapeutic value - Inclusion on List 1Bb with financial access arrangement | - Inclusion on List 1Aa – interchangeable drug with equivalent therapeutic value | Not issued |
Poland | - Major additional clinical benefit - Significant additional clinical benefit - Marginal additional clinical benefit | - Additional clinical benefit not quantifiable - Minor improvement of medical benefit, high price | - Not recommended |
Sweden | - Major additional clinical benefit - Significant additional clinical benefit - Marginal additional clinical benefit | Not issued | - No improvement of medical benefit and very high cost |
UK-England | - Recommended | - Recommended for restricted use - Recommended for restricted use with Patient Access Scheme | - Not recommended (or not recommended because of no submission) |
UK-Wales | - Recommended | - Recommended for restricted use - Recommended for restricted use with Patient Access Scheme | - Not recommended (or not recommended because of no submission) |
UK-Scotland | - Recommended - Recommended with Patient Access Scheme | - Recommended for restricted use - Recommended for restricted use with Patient Access Scheme | - Not recommended (or not recommended because of no submission) |