POSITIVE ACTION, A support group for women infected with hepatitis C in Ireland as a result of contaminated blood products has called on the HSE to fund the most up-to-date and effective treatments for its members.
Last week, the HSE’s monthly update of what drugs it will reimburse failed to include telaprevir and boceprevir despite their proven efficacy.
Speaking to TheJournal.ie, Detta Warnock, spokesperson for Positive Action, says the group feels very strongly that the treatments should be made available by the HSE.
The organisation, which represents 732 women who contracted hepatitis C from Anti-D injections between 1970 and 1994, says that a 1996 healthcare package granted to them under the Health Amendment Act provides for medication fee of charge.
“It is very important that it should be reimbursed,” adds Warnock.
The telaprevir and boceprevir treatments – when given with ribavirin and alpha interferon as a triple therapy – have seen impressive results in other countries. Warnock says that when the drug is added to the current dual treatment programme, success rates double from 40 per cent to about 80 per cent.
Although the treatment can improve a patient’s chance of getting rid of hepatitis C, the decision to undergo the treatment is not taken lightly.
“It is a chemotherapy based drug with huge side effects,” explains Warnock. “Women suffer flu-like symptoms, rash, anaemia and heavy but not complete loss of hair.”
It is a big undertaking, she says, that is much more favourable if the odds of working are increased.
Currently, there are some women receiving the most up-to-date triple treatment under a named-patient programme at the Mater hospital in Dublin but drug companies are footing the bill to get the product out to market.
Telaprevir has passed all the necessary licensing requirements but for it to be made widely available, it must be reimbursed by the HSE, concluded Warnock.
A growing concern for Pharma
A source at the Irish Pharmaceutical Healthcare Association (IPHA) told TheJournal.ie that its members have reported an increasing amount of medicines being held up despite having gone through the required regulatory processes.
It is a matter of great concern to the companies involved in bringing innovative products to Irish patients, he said.
As well as the obvious impact on patients, there is also a negative effect on business and decisions on future investment.
The IPHA is also aware of breakthrough drugs for MS patients being held up in a similar fashion.
The Irish healthcare system operates in a way which sees about 80 per cent of medicines funded by various State schemes – including the GMS and drug payment, long-term illness and hi-tech schemes.
The Government has told the IPHA that it wants at least €112 million in savings on its medicines bill in 2012. This follows the delivery of savings of €240 million by the industry over the past two years.
The last agreement between the IPHA and the Government included a clause that the State would continue to add new medicines to the reimbursement list to ensure as comprehensive supply as possible. That 2006 agreement which was extended in 2010 has now lapsed and negotiations between the two sides are continuing.
Value for money?
In a statement to TheJournal.ie, the HSE said that it continues to approve all medicines for which it believes there is robust evidence that they are “cost effective and budget neutral”.
In relation to telaprivir, it said that it expects a significant budget impact and has referred the product to the Drugs Group established in 2011 to consider how medicines can be introduced into clinical care pathways “as and when HSE resources become available”.
HSE is working with treatment centres to ensure that all appropriate arrangements and controls are in place to support optimal use prior to final approval by the HSE.
It is understood that treatment could cost up to to €50,000 per year per patient.
After an evaluation in January this year, the National Centre for Pharmacoeconomics said it considers telapevir a “highly cost effective therapy” when added to the current dual treatment of interferon and ribavirin of patients infected in the Irish healthcare setting.
About 1,200 women were contaminated with hepatitis C when they received anti-D immunoglobulin manufactured or distributed by the Irish Blood Transfusion Service between 1970 and 1994.
The blood product was administered to new mothers of a certain blood type to prevent haemolytic disease in the foetus of future babies. Warnock said that about 67 of Postive Action’s members have died since it was established in 1994.