The Italian Medicines Agency (AIFA) has granted reimbursement to new originator drugs and extended reimbursement of Roche's oncology treatment Avastin (bevacizumab) under new indications.
IHS Global Insight perspective | |
Significance | The Italian Medicines Agency (AIFA) has issued three reimbursement decisions concerning originator medicines. |
Implications | AIFA's decision allows the inclusion of Pfizer (US)'s Inlyta and ViroPharma (US)'s Plenadren in the national reimbursement list. In addition, the agency has extended reimbursement for new indications of Roche (Switzerland)'s Avastin (bevacizumab). |
Outlook | Inclusion of new medicines in the reimbursement list offers the opportunity to patients to get access to innovative treatments. In addition, access to funding puts manufactures in a favourable position to increase sales in the market. |
Pfizer's Inlyta gains reimbursement for advanced renal cell carcinoma treatment
Pfizer (US)'s Inlyta (axitinib) has been included in the Italian reimbursement list by medicines agency AIFA for the treatment of adults with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine. The drug has been granted classification H status, which indicates treatments approved and reimbursed for inpatient use, and has been approved for a maximum price of EUR884.22 (USD1,217.26; ex-manufacturer) and EUR1,459.32 (retail price) for 56 tablets at a strength of 1 mg. Under the terms of the agreement, a mandatory discount to public facilities is applied on the ex-manufacturer price. Furthermore, the negotiations have also established the application of a managed entry agreement based on a payment-by-results system. The contract is valid for 24 months. The decision was published on the Italian Official Gazette on 21 December and is available, in Italian, here.
Cancer drug Avastin secures approval for new indications
AIFA has also granted reimbursement to new indications for Roche (Switzerland)'s Avastin (bevacizumab). The drug has received classification H status for the treatment of bevacizumab in combination with carboplatin and paclitaxel, indicated for the front-line treatment of advanced (International Federation of Gynaecology and Obstetrics [FIGO] stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. The medicine has been approved for a maximum price of EUR1,289 (ex-manufacturer) and EUR221.47(retail price) for a 400 mg phial, and EUR321.85 (ex-manufacturer) and EUR531.18(retail price) for a 100 mg phial. The reimbursement is approved under the condition of a payment-by-results agreement. The contract is valid for 24 months as indicated in the provision published on the Official Gazette on 23 December. The decision is available, in Italian, here.
Plenadren included in the Italian reimbursement list
Meanwhile, ViroPharma (US)'s orphan treatment Plenadren (idrocortisone) has been approved for reimbursement for the treatment of adrenal insufficiency in adults. The drug received classification H status. The medicine is reimbursed at a maximum price of EUR273.00 (ex-manufacturer) and EUR450.56 (retail price) for 50 tablets at a strength of 5 mg and EUR454.00 (ex-manufacturer) and EUR749.28 (retail price) for 50 tablets at a strength of 20 mg. The decision was published on the official gazette on 28 December. The contract between the parties is valid for 12 months and foresees a mandatory discount to public facilities. In addition, an expenditure ceiling of EUR1 million has been set over the course of the 12-month contract. The decision is accessible, in Italian, here.
Outlook and implications
Approval for reimbursement of Pfizer's Inlyta and ViroPharma's Plenadren enables kidney cancer and adrenal insufficiency patients to get access to these innovative treatments. In addition, inclusion of the drugs to the reimbursement list may equip manufacturers with opportunities to further expand their sales in the Italian market. In particular, Inlyta has already demonstrated its potential in garnering substantial revenues. Over the course of the third quarter of 2013, Pfizer posted revenues growth for Inlyta up 186% year on year to USD83 million. Therefore, potential sales in Italy are expected to feed into these positive results in the short-to-medium term (see United States: 30 October 2013: Pfizer reports 2% decline in Q3 revenues despite double-digit growth in oncology products).
The indication extension for Avastin represents positive news for the Swiss manufacturer as the decision is likely to provide opportunities for sales increases in the Italian market. Avastin is the second top-selling product in Roche's portfolio. The sales for the drug were worth in the third quarter of 2013 CHF4.710 billion (USD5,283 billion), corresponding to an increase of 13% year on year (see Switzerland: 17 October 2013: Roche posts 3% growth in sales in first nine months, confirms full-year outlook). Roche faced a setback in the United Kingdom earlier this year when the National Institute for Health and Care Excellence did not recommend funding for the use of Avastin in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer (see United Kingdom - Switzerland: 22 May 2013: NICE issues final guidance not recommending Avastin in two ovarian cancer indications).