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ANALYSIS:
Monica Desai, Ellen Nolte, Nicholas Mays, and Athanasios Nikolentzos
International experience of paying for expensive medicines
BMJ 2009; 338: b1993 [Full text]
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Rapid Responses published:

[Read Rapid Response] Expensive cancer medications in Ontario, Canada
Irfan A Dhalla, Roger Chafe, Terrence Sullivan   (8 June 2009)
[Read Rapid Response] Issues in Controlling Drug Prices
Ajay G. Pise, Shilpa Pise, D. Sreedhar, Manthan J., Virendra L, N. Udupa   (10 June 2009)
[Read Rapid Response] How patients and oncologists may actually want to use 'top-ups'
Virginia J Warren   (12 June 2009)

Expensive cancer medications in Ontario, Canada 8 June 2009
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Irfan A Dhalla,
Clinician Scientist
St. Michael's Hospital, Toronto, Ontario, Canada M5B 1W8,
Roger Chafe, Terrence Sullivan

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Re: Expensive cancer medications in Ontario, Canada

Desai et al. illustrate that the structure of a country's health care system may affect its response to the problems raised by expensive medicines that are not funded publicly. As we have discussed elsewhere (1), insisting that unfunded medications be delivered only in private facilities would result in a de facto prohibition in many parts of Canada because of the lack of private clinics. Allowing unfunded drugs to be administered in public hospitals in Canada would also likely discourage the spread of private clinics, which may have implications for publicly-funded care, especially if these clinics recruit nurses and physicians from the public sector. Although we admit some discomfort with the notion that patients being treated in the same chemotherapy unit will receive different levels of care based on their wealth, we recognize that public resources are limited. If we are going to make the difficult decision not to publicly cover some expensive drugs, even when they extend survival or improve quality of life, we should not unnecessarily burden those who want to pay for these drugs themselves. The key issue is to ensure that these purchases do not adversely affect the public interest. The case of expensive intravenous medications used in the treatment of cancer is somewhat unique, given that most of the patients who would be paying privately would simply be substituting one drug for another in a multi-drug regimen. The hospitals would be covering most labour costs with or without the unfunded drug. This largely mitigates the objection that public funds will be used to subsidize private treatment.

In 2006, Cancer Care Ontario, the agency responsible for the provision of cancer care in Ontario, helped develop recommendations to provide guidance to hospitals on this issue. In March 2008, Cancer Care Ontario followed up with a survey of all sites where chemotherapy is provided. Slightly more than half the facilities were allowing patients to purchase unfunded medications. Of the 33 sites that provided unfunded medications, only 17 had a formal policy on the issue. Notably, only a tiny number of the 33 hospitals were charging the $250 infusion fee that a provincial working group recommended to offset preparation and administration costs to the public system. The most common drugs paid for in public hospitals were bevacizumab, rituximab, cetuximab, alemtuzumab, permetrexed and zoledronic acid.

We all agree that unfunded drugs raise difficult questions about the line between public and private care. As stressed by Mike Richards in his report (2), governments must do everything possible to limit the circumstances where effective drugs are not covered for patients with serious illness. Nevertheless, it is inevitable that some drugs will be too expensive to justify public expense. Each country will need to develop their own approach to dealing with unfunded medications, reflecting the particular burdens that its health care system places on both the patients who can afford to purchase unfunded drugs as well as those who cannot.

Irfan A Dhalla, Roger Chafe and Terrence Sullivan

1. Chafe R, Dhalla IA, Dobrow M, Sullivan T. Accessing unfunded cancer drugs in publicly funded hospitals. Lancet Oncology 2009; 10: 306-307.

2. Richards M. Improving access to medicines for NHS patients. London: Department of Health. http://www.dh.gov.uk/en/Publicationsandstatistics/Publicatio ns/PublicationsPolicyAndGuidance/DH_089927 (accessed March 10, 2009).

Competing interests: None declared

Issues in Controlling Drug Prices 10 June 2009
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Ajay G. Pise,
Lecturer
Manipal College of Pharmaceutical Sciences, Manipal-576104,
Shilpa Pise, D. Sreedhar, Manthan J., Virendra L, N. Udupa

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Re: Issues in Controlling Drug Prices

The analysis by Monica Desai and Colleagues on “International Experience of Paying for expensive medicines” is very informative. The concept of top-up payment for drugs is increasing globally. Pharmaceutical companies are taking advantage out of it. It has chances of increasing access to medications and creating more inequalities. In this context, government authorities of concern countries have to play decisive role in acceptance and encouragement of this concept.

As practised in England, decisions regarding funding for drugs are controlled by National Institute for Health and Clinical Excellence (NICE), it would have been cost effective if the same authorized body could empowered for appraisal and approval of medicine for circulation among Primary Care Trusts.

The special considerations and importance should be given by government authorities to reduce the cost of anticancer, antidiabetic and drugs used in cardiac diseases. The authors have recommended setting up of a separate private facility centres in parallel to NHS care for providing private care to the patients, we believe that such provisions would increase competency among private health care players and provide better service for patients at reasonable cost.

Competing interests: None declared

How patients and oncologists may actually want to use 'top-ups' 12 June 2009
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Virginia J Warren,
Public Health Physician
Bupa House, 15-19, Bloomsbury Way, London WC1A 2BA

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Re: How patients and oncologists may actually want to use 'top-ups'

Desai et al gave an interesting and informative 'Analysis' of top-up payments, but one which was, in respect of the UK, potentially incomplete. They only considered drugs for the indications for which they have their licences. The inset box reported audits by the Christie Hospital and the Rarer Cancers Forum: these reveal that oncologists believe that their patients would benefit from licensed drugs either not yet the subject of NICE guidance, or not approved by NICE. It is also the case that oncologists may be of the opinion that their patients would benefit from off-label chemotherapy and/or biological therapy. This is shown by analysis of requests for discretionary payments for off-label treatment for those of Bupa's 3 million UK members with malignant disease: Bupa (British United Provident Association) funds oncology drugs and biologicals in-licence routinely.

In the 12 months to 31 August 2008, 162 different off-label regimes were assessed for discretionary payment using an algorithm similar to that published for interventional procedures (1). Seventeen of these were for unlicensed pharmaceuticals. Of the remaining 145 for licensed drugs/biologicals, 75 were for different malignancies from those specified on the licence, 42 for unlicensed combinations with other pharmaceuticals, 25 for a different line of treatment, and three for a different stage of disease.

Bevacizumab was the compound most frequently involved (48 requests). Sixteen were for cancers for which it was not licensed, 18 for unlicensed combinations, and 14 for a line of treatment for which it was not licensed. Funding for off-label use of other drugs/biologicals was much less frequently sought (lapatinib six, trastuzumab and sorafenib five each, bortezomib and rituximab four each; the modal number of requests per agent was one).

Twenty of the regimes were declined funding, because they were unsupported by evidence (eg thalidomide and dexamethasone for hormone resistant prostate cancer). Fourteen were funded in the context of trials (but not otherwise), 115 were funded as one-offs because of the patient's clinical circumstances, and 13 of the regimes were funded routinely at this first request, and subsequently.

This data suggests that the use of top-ups in the UK may well turn out to be more common than Desai and colleagues anticipate, and that these episodes would very often be clinically justifiable.

1) Warren V. Health technology appraisal of interventional procedures: comparison of rapid and slow methods. J Health Serv Res Policy 2007;12:142-6.

Competing interests: Bupa does offer private medical insurance: it does not offer a 'top-up' product