The Italian Medicines Agency has granted reimbursement to two new originator drugs and extended funding for a new indication.
IHS Global Insight perspective | |
Significance | The Italian Medicines Agency (AIFA) agreed to grant funding to two new originator treatments and extended reimbursement to a drug for a new therapeutic indication. |
Implications | Takeda's Instanyl (fentanyl) and Roche's Zelboraf (vemurafenib) are now included on the Italian reimbursement list. Patients will now be provided with the possibility to fully access the reimbursed drugs at outpatient and inpatient level. |
Outlook | The inclusion on the Italian reimbursement list represents an opportunity for the manufacturers as sales may be positively impacted further to AIFA's decisions. |
The Italian Medicines Agency (AIFA) has approved three originator drugs for reimbursement. The decisions were published on the Italian Official Gazette on 4 June. The full text of the decisions is available, in Italian, here.
Takeda's Instanyl gets green light for funding in Italy
Japanese pharmaceutical company Takeda's Instanyl (fentanyl) has been approved for funding in the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer. The drug has been granted classification H status, which indicates drugs that are only reimbursed within hospitals or equivalent institutions. The maximum price approved for reimbursement is EUR13 (USD17.3; ex-manufacturer) and EUR21.46 (retail). The contract is valid for 24 months and a mandatory discount is applied to public healthcare facilities.
Zelboraf added to the reimbursement list
AIFA has granted classification H status to Roche (Switzerland)'s Zelboraf (vemurafenib) in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. The maximum price approved for reimbursement is EUR2,300 (ex-manufacturer) and EUR3,795.92 (retail). The contract is valid for 24 months and is subject to a risk-sharing agreement based on a pay-by-results scheme. Responder patients are entitled to receive a free DNA test. The parties have agreed an expenditure ceiling of EUR36 million for the duration of the contract.
Schizophrenia treatment Invega obtains reimbursement for new therapeutic indications
AIFA has granted reimbursement to Invega (paliperidone; Janssen subsidiary of Johnson & Johnson, US) for the new therapeutic indication of treatment of psychotic or manic symptoms of schizoaffective disorder, with the note "effect on depressive symptoms has not been demonstrated". The drug has been given A classification, indicating that it is fully approved for outpatient use. The drug has been approved for a maximum price of EUR89.60 (ex-manufacturer) and EUR147.88 (retail) for a 28-tablet blister pack of 3 mg and 6 mg, and EUR151.20 (ex-manufacturer) and EUR 249.54 (retail) for a 28-tablet blister pack of 9 mg. In addition, the provision specifies that mandatory discount has been agreed between the parties be applied to public healthcare facilities for the duration of the 24-month contract.
Outlook and implications
Roche's Zelboraf has secured a new positive reimbursement decision further to the agreement signed with eight Swedish counties (see Switzerland - Sweden: 4 June 2013: Eight Swedish county councils sign agreement with Roche on Zelboraf). The revenues growth opportunities may be mitigated by the cost-containment measures agreed by the parties, namely expenditure ceiling and cost-sharing agreements. However, the approval will provide Roche with the opportunity to further boost the sales of Zelboraf; during the first quarter of 2013, Zelboraf reported sales growth of 84% year-on-year to CHF154 million (USD166 million; see Switzerland: 11 April 2013: Roche posts 5% sales growth in Q1).
Instanyl, which became part of Takeda's product portfolio further to the acquisition of the Swiss pharmaceutical firm Nycomed in 2011, was approved for marketing authorisation in Europe in July 2011 (see Switzerland: 6 July 2011: Nycomed Wins EU Approval for Instanyl Single-Dose Nasal Spray). The drug has been recently included in the positive reimbursement list of several EU countries providing Takeda with the opportunity to further expand its business in the EU market.