2009 - 2013
The bulk of funding invested in medicines managed by PHARMAC goes to treat conditions and diseases that affect large numbers of patients – from arthritis to asthma, diabetes to depression.
But it is a little known fact that around 80 percent of patients receiving funded medicines in New Zealand account for just 9 percent of the Combined Pharmaceutical Budget (CPB). Most people’s medicine needs are met very efficiently, while a small number of patients require highly specialised and often expensive medicines.
That latter group comprises a relatively small number of patients with rare and sometimes hard-to-treat conditions. Part of running an equitable process for acquiring medicines is considering the needs of those patients with so-called ‘exceptional circumstances’.
Since its early days, PHARMAC has allocated some of its budget each year to treat people with medicines that fall outside of the Pharmaceutical Schedule funding process.
Three schemes are operated by PHARMAC as part of the Exceptional Circumstances Framework , designed to offer access to community, hospital and cancer medicines for individuals who can demonstrate that they meet exceptional circumstances criteria.
“They might be the only person in New Zealand with their particular condition,” explains Carolyn Gullery, an original PHARMAC Board member.
“They might be the only person who needs that particular product rather than the normal one we use.”
“This put a human face on PHARMAC,” says former PHARMAC chair Richard Waddel.
“There might only be two cases in New Zealand and it is going to cost a million dollars per case. If it is such a huge benefit, it is very, very hard when you say it doesn’t fit the criteria. You are dealing with a person’s life.”
“You are dealing with a person’s life.”
– Richard Waddel
Decisions considered by the Exceptional Circumstances Panel, which consisted of up to six clinicians, could be particularly contentious.
“These were very difficult cases because you had to review the emergent literature,” says Sharon Kletchko, who considered many funding decisions as a member of the Panel.
“For someone interested in pharmacotherapeutics and rare conditions it was groundbreaking stuff.”
She remembers, in the early days, reams of paper spitting out of her fax machine as medical research was sent to her ahead of the Panel’s regular Tuesday night teleconference to consider the applications.
Often a person’s clinical circumstances would meet the spirit or intent of the conditions within the Pharmaceuticals Schedule, but not meet the technical requirements. PHARMAC allowed some discretion in decision making and the Exceptional Circumstances Panel was on the frontline of that decision making.
“We had a budget and weren’t allowed to go beyond it without PHARMAC giving approval. It meant that we as clinicians carried the decision,” says Kletchko.
In 2010 PHARMAC opened consultation as part of a review of its Exceptional Circumstances scheme . This resulted in the creation in 2012 of the Named Patient Pharmaceutical Assessment (NPPA) policy, a new scheme with some significant changes. Patients would no longer need to have a rare condition (be one of a maximum of 10 patients in the country with the condition) to be considered for funding and PHARMAC created a pathway to assess treatments more quickly for patients whose condition would deteriorate or who would miss an opportunity to improve while a typical Pharmaceutical Schedule application was made.
The funding for exceptional circumstances was also doubled from $4 million to $8 million in the following year. It recognised the demands on the scheme and the need for greater flexibility in dealing with the most acute patient cases with the move to managing the hospital medicines portfolio.
“The new scheme is more permissive and more clearly describes PHARMAC’s discretion to consider funding applications not meeting the letter of the scheme,” said PHARMAC chief executive Matthew Brougham in announcing the new scheme in June 2011.
“We expect that one of the results of the change will be that more conditions experienced by small groups of patients will be considered for funding. Rarity is no longer the key consideration in examining funding applications; instead we will focus on patients with unusual clinical circumstances, or those whose conditions are urgent and serious,” he added.
The Exceptional Circumstances Framework and NPPA continue to be integral to the decision-making processes of PHARMAC, with thousands of applications received every year and a high level of scrutiny of decision outcomes.
2009 - 2013
Last updated: 13 September 2018