Skip to main content

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)
  1. Sources: Websites of HTA agencies of the eight countries included in the table
  2. Notes: aList 1A includes generics, parallel imported medicines and new dosages of medicines that are already included in the reimbursement list. A shortened reimbursement procedure is possible for such drugs, whereby the Ministry of Health, Welfare and Sport decides on the inclusion of the drug in the Medicine Reimbursement System without the input of the Health Care Insurance Board; 90% of the medicines in this category are fully reimbursed. Products in this category are clustered and reimbursed at an average price. bProducts which cannot be clustered, but are reimbursed at the market price, are published on List 1B. Conditions for including a medicine in List 1B are based on the assessment of the therapeutic value and cost-effectiveness. If the therapeutic value of the medicine is too low, it will not be eligible for reimbursement. Maximum wholesale prices are the only cap on the reimbursement price