NZ in top rung of nations funding new cancer drug
NZ in top rung of nations funding new cancer drug
New Zealand will become one of the first countries in the world to fund imatinib mesylate (Glivec) as a first line treatment for chronic myeloid leukaemia, should the new therapy be approved for this use by the Ministry of Health.
PHARMAC has agreed to fund Glivec for all patients for whom it is currently approved for use. Glivec can currently be used to treat people in the accelerated and blast crisis phases of chronic myeloid leukaemia (CML), those in the chronic phase who are intolerant of the current first-line treatment interferon-alpha, and people with unresectable and/or metastatic gastrointestinal stromal tumours (GIST).
This decision will see up to 120 people immediately qualify for fully subsidised Glivec from 1 December 2002.
In addition, PHARMAC has agreed that Glivec would be funded as a first line therapy, subject to approval by the Ministry of Health’s drug assessment agency Medsafe and a positive recommendation from the Pharmacology and Therapeutics Advisory Committee (PTAC). Up to 90 further people could then receive the drug fully subsidised.
“We are delighted to be able to provide funding for as many people as are currently eligible to be treated with Glivec,” says PHARMAC Chief Executive Wayne McNee.
“This is an extremely comprehensive funding agreement that would see New Zealand among the first nations in the world to fund Glivec as a first line therapy for CML, though this approval is dependent on Medsafe approving the drug for this indication and a positive recommendation from PTAC.”
PHARMAC has agreed to list Glivec on the Pharmaceutical Schedule at a price of $4800 per pack, which will be about a month’s supply. The agreement also includes confidential price reductions, rebates and other risk sharing arrangements on a number of Novartis products used in both the community and in hospitals.
Another notable feature of the agreement is that it is the first time PHARMAC has approved funding for a combination of products used in both the community and hospitals. This follows PHARMAC assuming responsibility for managing hospital pharmaceutical expenditure on behalf of District Health Boards earlier this year.
2/Pharmac Glivec funding
“The clinical evidence shows Glivec both prolongs and enhances the quality of life for some people with chronic myeloid leukaemia, and gastro-intestinal stromal tumours. We are extremely pleased that Novartis has been willing to come up with such a comprehensive and innovative proposal to enable PHARMAC to agree funding for a wide group of New Zealanders, and to provide cost savings and benefits in other areas.”
“PHARMAC believes this agreement is affordable and sustainable for New Zealand, and will enable other drugs on our priority list to be funded from within the allocated pharmaceutical budget. That makes this agreement good news for patients and all taxpayers.”
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August 2001: The Pharmacology and Therapeutics Advisory Committee (PTAC) assesses a funding application for Imatinib mesylate (Glivec), which has not yet been approved for use in New Zealand.
October 2001: Glivec is approved for use in New Zealand by the Ministry of Health, for chronic myeloid leukaemia (CML) patients in blast and accelerated phases, and for patients in chronic phase who have failed interferon-alpha treatment.
November 2001: PTAC comments that the drug is very expensive and not cost-effective, but suggests more clinical advice should be sought from a specialist cancer treatments sub-committee.
January 2002: PHARMAC appoints a new cancer treatments sub-committee, CaTSOP.
February 2002: CaTSOP considers imatinib, recommends priority funding for accelerated and blast crisis phase patients, and for interferon-intolerant chronic phase patients if funding is available.
February 2002: CaTSOP’s recommendations are considered by PTAC. PTAC recommends high priority be given to funding imatinib in the late stages of CML.
March-April 2002: Negotiations take place between Novartis and PHARMAC.
May-July 2002: PHARMAC consults on a proposal to fund imatinib for patients in the accelerated and blast crisis phases of CML.
July 2002: Following consideration of the consultation feedback, PHARMAC decides not to implement its funding proposal and re-enters negotiations with Novartis to reach an agreement for a wider group of patients.
July 2002: Medsafe approves imatinib for use as a treatment for unresectable and/or metastatic gastro-intestinal stromal tumours (GIST).
September 2002: PHARMAC consults on a proposal to fund imatinib for all patients for whom the drug is currently approved (interferon alpha-failed chronic phase CML, accelerated and blast crisis phase CML, unresectable and/or metastatic GIST), and as a first line treatment for chronic phase CML when this is approved by Medsafe.
October 2002: PHARMAC approves funding for imatinib.