 |
| About Bioline | All Journals | Testimonials | Membership | News |
|
||||||
|
||||||
Indian Journal of Cancer, Vol. 46, No. 3, July-September, 2009, pp. 179-181 Editorial Everyone is concerned about costs! Bhattacharyya GS, Malhotra H, Ranade AA, Raghunadharao D Head of Medical Oncology, AMRI, Kolkata Code Number: cn09039 PMID: 19574666 In today′s global economic meltdown it is both fashionable and essential to talk about healthcare cost and how to reduce it. It is surprising to note that illness and medical bills lead to half the personal bankruptcies in United States of America. Over 75% were actually medically insured at the start of the illness leading to bankruptcy. In fact those with cancer had an average medical debt of US$ 35,878 (almost Rs 18 lakh). [1] Nowhere is its impact as profound as in oncology, where current therapy is sub-optimal, new treatment options are rolling out every month and they involve expensive medication. [2],[3] Hence, additional new terminology in cancer care includes contribution working capital, human resource costs, practice efficiency, and opportunity costs. And no wonder the 2009 NCCN Slogan is Economizing Cancer Care! Sharma et al , in the review, in this issue of Indian Journal of Cancer, have broadly categorized costs to include direct cost of treating the cancer, indirect cost accrued by the patient′s family and the economic losses to the society as a whole. [4] However, every cost cannot be measured in terms of rupees or dollars. There is often an intangible cost (or benefit) that is difficult to understand, leave alone measure. To quote an anecdotal experience - A 45-year-old lady presented with extensive bony and visceral metastasis from breast cancer. During the discussion, she and her family expressed desire to undergo any treatment that would keep her alive for the next three months so she could participate in her elder daughter′s wedding. She underwent aggressive systemic therapy. She went into complete remission, enjoyed organizing her daughter′s wedding, was able to play with her granddaughter for two years and even went on to witness the wedding of her second daughter. On her death bed, she thanked the doctors profusely for giving her life! Her husband even sent a letter expressing how the treatment had infused joy in their lives for four full years - how they experienced hope when they were faced with nothing but despair and death. This clearly highlights the intangible benefits of treating patients as human beings - which administrators and financers cannot fathom. It also emphasizes the reason why some of us chose to become real doctors, knowing fully well the 24x7 nature of the job. Most cost-benefit and cost-effective analyses talk about the scenario in North American or Western Europe.[5],[6] For instance, the review article quotes that out of pocket non-medical costs can consume up to 26% of the weekly budget of the family and may amount to more than the medical cost. [7] The scenario is quite different in other geographies, particularly in developing countries like India. [3],[8] Cost of home-care for three months was calculated in US as US$ 4563. In India this would seem funny (if not ridiculous) since our cost would only be a fraction of this figure. To compare costs across geographies and varying socio-economic environments, it is important to understand the cost implications of events and activities. Parikh et al had devised one such algorithm called the ′Events and Activities Template′. This showed how each component of patient management has varying cost implications. The template can actually help predict how changes in patient management (interventions and complications) will alter costs differently in different countries. This tool was so powerful and the implications (for reimbursement) so profound that the hospital administrators blocked its publication (personal communication Parikh PM). Let us now move on to the example of lung cancer in Sharma et al ′s paper. [4] The main cost is quoted as US$ 45,897 for two years of treatment with main cost being hospitalization. [2] One of the most active components of lung cancer therapy is gemcitabine. This pro-drug needs to be activated in the body by the enzyme deoxycytidine kinase. This enzyme is the rate-limiting step being saturated in 30 minutes. [9] So the logical step was to increase infusion time to more than 30 minutes. This would make more active drug available to the body (instead of being wasted without being activated). Such a process would also potentially enable us to get the same efficacy at a much lower dose. When the local affiliate of the concerned company was approached, they were delighted at this "major breakthrough" and were fully supportive. Unfortunately, the head quarters, being more concerned about its global sales and resultant financial implication for its shareholders decided otherwise. So Science (longer infusion with smaller but effective dose) and patient benefit (reduced cost) lost out. A handful of persistent oncologists pursued this globally and, today, low dose prolonged infusion gemcitabine has become the accepted norm in several countries including India - providing superior results at 33% of the cost (when compared to labeled dose). [9],[10] That brings us to the discussion on "off label" use of drugs. [11],[12] The standard criticizm of such use is that "expensive" medicines are being "wasted for unproven benefit. Actually, off label use of drugs is highly prevalent in oncology. This is only to be expected when regulatory authorities behave unreasonably. For instance, it is difficult to believe that US FDA has not yet approved the use of IV vinorelbine in the management of advanced breast cancer (approved by EU). Today, approved indications are very restrictive defying common sense. [12] For instance, 5FU is labeled for use in "digestive tract cancers" (very general) whereas cetuximab is labeled for use "in combination with irinotecan for colorectal cancers pretreated with irinotecan and that express the receptor ERBB1" (unduly restrictive). The frequency of such "off label" use is seen in up to a third of patients (with some specific cancers being even higher - 58% in hormone refractory prostate cancer [HRPC]). [11] In fact ESMO has recommended that EMEA actually have a list of acceptable indications for off label use of cancer drugs.[13] This also highlights the need to change the stringent laws in India that make off label use illegal. This is especially important in the light of the fact that only the pharmaceutical company holding the license can apply for changes in the labeled indication - an expensive procedure that may not be pursued if their calculation might indicate too little profit from it. Recently the use of Viagra for the management of a congenital heart condition in newborns and infants put this to test. Fortunately, this decision of the treating physician was upheld as in the best interest of the patients. The French have already gone a step further by having a list of accepted off -label uses called temporary therapeutic protocols. A recent editorial by DeVita also stated that if MOPP had to go through the current requirements .. "it would take decades and many patients alive today would have been dead". In the Indian context, majority of the costs fall upon the family and patient - so the financial impact is rarely studied or published systematically. Should we then rely on self-reporting by patients and their family members? The answer is obviously not. Some families will exaggerate costs - including accommodation and food for the entire family, not only the primary care giver). Others may declare only a fraction of the cost that they will be showing in their audited accounts. We have seen examples of both extremes as well as all the shades between. This does not diminish the importance and impact of cost on management of cancer. The first advantage that patients in several of the developing countries take is the availability of generics, often available at a fraction of the cost. The question is whether this is really cost-effective. Be it original molecule or the generic, quality of the medication is of vital importance for ensuring that the patient receives the dose required by the chemotherapy protocol. It is well know that a reduction of 10% in the dose delivered can result in as much as 50% reduction in cure rates in several cancers. This fact needs to be emphasized and publicized. In some instances patients can benefit from expensive medicines by taking advantage of patient access programs. However, such programs need to be closely evaluated. Some innovator pharmaceutical companies use a very restrictive "access" program simply to avoid compulsory licensing under the TRIPS agreement. The answer is to look at the cost effectiveness of the treatment in its entirety. Let us take the example of G-CSF to prevent neutropenia. [13] Initially, ASCO guidelines recommended its prophylactic use only if the potential of the chemotherapy schedule to result in significant neutropenia (grade 3 and 4) was more than 40%. Subsequently this cut off was reduced to 20%. What was the cause of this change? The answer was simply drop in the cost of G-CSF (which was 100 US$ per dose). In India, the use of G-CSF has always been more prevalent. This has been justified in several ways. First, the cost of G-CSF in India is only a tiny fraction of US price. Second, the cost of hospitalization (bed charges) is dramatically different between developed and developing countries. Third, in case of febrile neutropenia, the cost of antibiotics in India would quickly become the most expensive component of the treatment - even higher than the cost of chemotherapy. Fourth- the cost of morbidity and mortality due to challenging logistics - some of which include difficult terrain, inaccessible medical facilities and inability to reach hospital within 24 hours of onset of fever. This clearly shows that prophylactic use of G-CSF was, is and shall remain "standard" of care in India (and many developing countries) for majority of patients receiving aggressive chemotherapy, beyond the scope of even the revised ASCO recommendations. Let us also take into consideration one other challenge. Can oncology practices and clinics increase their efficiency while reducing frequent clinic visits without compromising on patient care? If the answer is yes it benefit′s patients′ by providing the potential to significantly reduce patients′ and caregivers′ out-of-pocket costs. An additional benefit would be reduced loss of work productivity amongst patients and their relatives. The point remains that we must find innovative ways to address cancer care costs in India. We cannot expect answers for cancers primarily prevalent in developing countries (e.g. Head and Neck Cancer) from anyone else except us. Another example is chemotherapy extra-vasation. With venous access devices used in most (if not all) patients, this problem does not exist in the West. However, it continues to cause significant morbidity, results in interruption of chemotherapy and compromises on dose intensity enough to vaporize chances of cure and even adds the need of plastic surgery to take care of painful non-healing ulcers. Prompt institution of simple oral proteolytic enzyme combination medication can not only prevent their occurrence but also heal extra-vasation ulcerations without need of plastic surgery or affecting dose intensity. [14] Such cost effective innovations are the need of the hour. Instead, authorities play around with numbers, twisting statistics, to suit their stated position without any consideration of patients. Therefore, in a physician-patient dialogue, patients′ wellbeing, rather than management costs, should continue to remain the primary focus. Administrators or doctors should not alter recommendations of proven effective treatment to reduce budgets. It is good that efficacy and safety (as opposed to costs) continue to remain the major focus of US FDA reviews. Clinical practice guidelines from scientific and academic organizations (like NCCN and ASCO) also contribute to the approval of new anti-cancer drugs purely on the basis of efficacy, costs being mentioned only for information purposes. We must remember that our first duty is to do "what is right and necessary" for the patients. [12] References
Copyright 2009 - Indian Journal of Cancer |
| |||||||||
