A breakthrough drug? How soon can I start?

The delay between hearing about a new treatment and starting it is often the result of the time it takes to assess its cost effectiveness…

The delay between hearing about a new treatment and starting it is often the result of the time it takes to assess its cost effectiveness, writes MUIRIS HOUSTON

IT’S EXCITING when a treatment breakthrough is announced for a disease likely to affect many of us, such as cancer, diabetes or stroke. And for those with the disease, the natural reaction is: how soon can I start the new drug?

Not so long ago, the answer was: as soon as the new treatment has been approved by the Irish Medicines Board. Once a drug got its licence, the company put it on the market, doctors began to prescribe it and the Health Service Executive (with a few exceptions) covered the cost for medical card patients.

Now, however, the process extends further and governments will generally not pay until the cost effectiveness of a particular treatment has been proven.

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The scientific mechanism used to assess cost effectiveness is called health technology assessment or HTA. Next month, the Republic has the not inconsiderable honour of hosting the world Health Technology Assessment International (HTAi) conference, bringing more than 1,000 delegates to Dublin for the largest healthcare conference to be held in Ireland this year. They will meet for four days from June 6th to 9th to discuss a broad range of issues, many of which will impact on patients here (see panel).

HTA is more than just euros and cent. Covering drugs and medical devices, HTA is defined as a systematic transparent process to summarise information on the medical, social, economic and ethical issues related to the use of a new or established health technology.

“HTA seeks to ensure that we will invest in those technologies such as drugs, devices and screening programmes that will deliver the best health gain for the population within the constraints of the fixed healthcare budget,” says Dr Máirín Ryan, director of HTA with the Health Information and Quality Authority (Hiqa), and the principal organiser of the international conference.

In collaboration with the National Centre for Pharmacoeconomics at St James’s hospital, Hiqa has recently undertaken a number of key HTAs, which demonstrate the central role of the process in deciding important public health issues. Given the severe economic conditions, it is fair to say that neither HPV vaccination against cervical cancer or bowel (colorectal) cancer screening would have been approved without a HTA.

An initial HTA showed that colorectal cancer screening is highly cost effective, delivers substantial health benefits in terms of lives saved and cancers avoided, but requires a large number of colonoscopies to further investigate those who have a positive result on the screening test. Then, according to Dr Ryan, the Minister for Health asked Hiqa to consider an alternative implementation scenario building on the resources of the current cancer screening services.

“Our evaluation outlined a plan to utilise the current colonoscopy suites in the public hospitals over an extended day, train additional staff including nurses to deliver the colonoscopies and use the existing administrative resources in the National Cancer Screening Service. The new approach saved €15 million on capital expenditure, €5 million on implementation costs and €3-€6 million per year in running costs once fully rolled out.

“Therefore, the evaluation provided an affordable alternative that informed the Minister’s decision in January to invest in a national colorectal screening programme while also providing for the integration of the current symptomatic and the new screening colonoscopy services,” Ryan says.

And what about giving patients a say, especially with pressure to complete HTAs in 90 days? According to expert Dr Karen Facey, of the University of Glasgow, a conference session will look at the opportunities and limitations of using social networking and patient blogs to gather evidence on patients’ perspectives.

Ryan firmly rejects the notion that by promoting HTA, Hiqa is acting as a “cost policeman”. While acknowledging the influence of the UK national institute of clinical excellence (Nice) – which has caused controversy in the past by not recommending some cancer treatments – in creating such an impression, she stresses an important difference.

“Nice carries out the review and issues guidance, the acceptance of which is mandatory. We carry out a HTA, but the decision on whether to accept our recommendation lies with the Department of Health and the HSE.”

For conference details, see htai2010.org

BEST IN PRACTICE: ASSESSING THE TREATMENTS

Next month's HTA conference in Dublin will examine a number of specific treatments and health interventions. Included are the following examples of direct relevance to patients in the Republic:

Which works best for abdominal operations: robotic surgery (using the Da Vinci system) or laparoscopy (operating through a small incision in the tummy using a flexible telescope)?

Should we add DNA testing for the Human Papilloma Virus (HPV) to smear testing when screening for cancer of the cervix?

How to tailor the use of PET and CT scanning to maximise the cost effectiveness of diagnosing cancer.

Is there a role for robot-assisted gait therapy in the treatment of stroke patients?

The cost effectiveness of screening for prostate and colorectal cancers