Brazil's health technology assessment body CONITEC recently issued one negative reimbursement decision and two positive decisions relating to the national healthcare system's basic list of free medicines during October and November.
IHS Global Insight perspective | |
Significance | Brazil's health technology assessment (HTA) body CONITEC issued one negative reimbursement decision for the national healthcare system (SUS)'s basic list of free medicines in November in relation to wet AMD drug Lucentis (ranibizumab; Novartis), and two positive decisions in October for antiretroviral (ARV) Celsentri (maraviroque; GlaxoSmithKline) and Somatuline Autogel (lanreotide acetate; Ipsen) for the treatment of acromegaly. |
Implications | The incorporation of a drug for the treatment of acromegaly and a new ARV are important tools for boosting the coverage of potential life-threatening diseases through the national healthcare system. The negative decision for Novartis's Lucentis is linked to cost-effectiveness analysis. |
Outlook | Following on from a recent wave of mixed positive and negative reimbursement decisions for drugs incorporated into the SUS, the latest decisions further move towards more transparency in the Brazilian HTA decision process, as well as helping to strengthen the pipeline of drugs available to patients through the SUS. |
Brazil's health technology assessment (HTA) body CONITEC issued a negative reimbursement decision for the national healthcare system (SUS)'s basic list of free medicines in November for wet age-related macular degeneration (AMD) drug Lucentis (ranibizumab; Novartis, Switzerland) and two positive decisions in October for antiretroviral (ARV) Celsentri (maraviroque; GlaxoSmithKline, GSK, UK) and Somatuline Autogel (lanreotide acetate; Ipsen, France) for the treatment of acromegaly.
According to CONITEC, after having revised the clinical studies provided by Novartis for Lucentis, the drug was rejected on the basis of a cost-effectiveness comparative study between the active pharmaceutical ingredient (API) ranibizumab and bevacizumab. According to the source, the price per 0.23ml vial of ranibizumab is BRL777 (USD 363), whereas the cost of a 4ml vial of bevacizumab is BRL964,98, making it more cost effective for the government to purchase a bigger 4ml bevacizumab vial for use through the SUS. The decision was also based on a study evaluation of the two drugs proving that ranibizumab is not in any way clinically superior to bevacizumab, as ranibizumab represents a fraction of bevacizumab's original molecule.
Somatuline Autogel was granted positive reimbursement status for the clinical treatment of symptoms associated with acromegaly, a syndrome resulting in the anterior pituitary gland producing excess growth hormone (GH), commonly resulting in the development of tumours or adenomas. The drug has also been approved by ANVISA for other indications related to the disease, which include treatment of acromegaly when the secretion of GH and GF-1 hormones stay abnormal after surgery or radiotherapy and in the treatment of neuroendocrine tumours. In its final decision, CONITEC mentioned that in terms of cost effectiveness, lanreotide acetate is comparable to an older acromegaly treatment already incorporated into the SUS, Sandostatin LAR (octreotide acetate). CONITEC decided to incorporate acetate as an alternative treatment for acromegaly as it is easier to administer to patients and can be taken with more prolonged intervals for some patients, which makes its quite cost effective. With the introduction of lanreotide, patients and the SUS will be able to alternate the two treatments according to their needs.
Lastly, CONITEC's decision to incorporate GSK's Celsentri as a third-line antiretroviral HIV treatment is a strategic addition to the SUS's already established pipeline of HIV treatments. Specifically, CONITEC has suggested incorporation for the drug as a possible option for those patients with a long history of HIV treatments and in need of a third–line treatment due to resistance to other therapies. The only condition set by the government in this respect is that the daily price of the maviroque treatment is not superior to the ARV drug raltegravir, which is considered as a cost basis by the government.
Outlook and implications
The incorporation of Somatuline for the treatment of acromegaly and the new ARV drug Celsentri is positive news for the SUS as these drugs represent important treatment tools for boosting the coverage of potential life-threatening diseases. Specifically, the incorporation of Celsentri comes as part of a new governmental strategy to meet internal demand for ARV drugs and therefore enable the sustainability of the government's national HIV programme, which covers 17,000 Brazilians: this is particularly important in light of the recent World AIDS Day that took place on 1 December.
CONITEC's negative reimbursement decision for Lucentis is based on a cost-effectiveness study proving that a 0.23ml vial of ranibizumab is in comparison much more expensive than a much larger 4ml vial of bevacizumab. Wet AMD is not Lucentis's only therapeutic indication, as it is prescribed for diabetic macular edema and macular edema following retinal vein occlusion.
The incorporations are positive news for GlaxoSmithKline and Ipsen, which will be able to negotiate with the Brazilian government on providing supplies of the requested drugs.
Part of the Ministry of Health (MoH), CONITEC was created in December 2011 via Decree 7.646, with the aim of ensuring transparency and speeding up the process of incorporation of drugs into the SUS. In a further effort to create a strongly transparent HTA environment, the MoH has created a new Department of Management and Incorporations of Health Technologies within the Secretary for Science and Technology that effectively is responsible for helping CONITEC to carry out its duties. The creation of the new department was detailed in Article 31 of Decree 7797 2012 published in August 2012.