The Swedish Dental and Pharmaceutical Benefits Agency has issued four positive reimbursement recommendations and one negative.
IHS Life Sciences perspective | |
Significance | The Swedish Dental and Pharmaceutical Benefits Agency (TLV) has issued four positive reimbursement decisions and one negative recommendation. |
Implications | Three innovative drugs have been included in the Swedish reimbursement list, namely Bristol-Myers Squibb's diabetes drug Xigduo, Celgene (US)'s cancer drug Imnovid, and, further to a reassessment conducted by the TLV, Sanofi's multiple sclerosis treatment Aubagio. Furthermore, the infertility biosimiar drug Bemfola has also secured reimbursement in the Swedish market. Conversely, a negative decision was issued for Roche's oncology product Erivedge. |
Outlook | Access to the national reimbursement list is likely to increase patients' access to the treatment as well as boost the companies' sales. |
BMS's type 2 diabetes treatment Xigduo obtains reimbursement in Sweden
The Swedish Dental and Pharmaceutical Benefits Agency (TLV) has recommended for reimbursement the Bristol-Myers Squibb (BMS, US) diabetes drug Xigduo (dapagliflozin + metformin) in the treatment of type 2 diabetes mellitus in adults aged 18 years as an adjunct to diet and exercise to improve glycaemic control. The pharmacy purchase price (PPP) approved for the drug is SEK436.54 (USD64.87) for 54 tablets of 5mg/850 mg or 5mg/1,000mg and SEK1,527.89 for 196 tablets of 5mg/850mg or 5mg/1,000mg. Xigduo is a combination medicine containing sodium-glucose co-transporter-2 (SGLT-2) inhibitor dapagliflozin and metformin. The relevant comparison for Xigduo is the combination of BMS's Forxiga (dapagliflozin) and metformin. TLV's assessment is that Xigduo provides an equally beneficial effect on glucose control as the alternative, but at a lower cost. Against this background, the TLV has decided that Xigduo should be included in the reimbursement system effective from 4 June. The full reimbursement decision is available, in Swedish, here.
Thumbs up for infertility biosimilar Bemfola
The TLV has also granted reimbursement to the biosimilar drug Bemfola (follitropin alpha; Finox Biotech, Switzerland) for the treatment of infertility: in women who do not produce eggs and who do not respond to treatment with clomiphene citrate; in women who are undergoing assisted reproductive techniques such as in vitro fertilisation (IVF); in women with severe deficiency of luteinising hormone (LH) and follicle-stimulating hormone (FSH); and in men who have hypogonadotrophic hypogonadism. The reimbursement of Bemfola, however, has not been granted in Sweden for human oocyte cryopreservation. The approval for commercialisation in Europe has established that the clinical efficacy and safety profile of Bemfola is comparable to that of its reference product, Gonal-f (follitropin alpha; Merck KGaA, Germany). Since Bemfola, compared with Gonal-f, provides the same benefits at a lower cost, the drug has been judged cost-effective and the agency has decided to include it in the reimbursement list. Furthermore, FSH preparations may also be offered to women without direct medical reason. However, the treatment is not subsidised by the Swedish healthcare system for women who wish to undergo IVF through oocyte cryopreservation without medical reasons. The PPP approved for the drug is SEK1,031.46 for 0.75 ml, SEK370.00 for 0.25 ml, SEK592.38 for 0.375 ml, SEK791.38 for 0.5 ml, and SEK167.46 for 0.125 ml. The decision was effective from 20 June. The full decision in available, in Swedish, here.
Multiple myeloma treatment Imnovid obtains positive endorsement for reimbursement
Celgene (US)'s Imnovid (pomalidomid) has also been included in the reimbursement list by the TLV. The drug has been approved in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. Imnovid is classified as an orphan drug. The drug, in combination with low-dose dexamethasone, has been shown to be beneficial compared with high-dose dexamethasone, both in terms of progression-free survival and overall survival. TLV has estimated that the cost, in relation to the medical effect and very high severity of the disease, is reasonable. Against this background, the TLV has determined that Imnovid should be subsidised. The PPP approved for the drug is SEK72,624.00 for 21 capsules of 1mg each, SEK73,765.00 for 21 capsules of 2mg, SEK74,905.00 for 21 capsules of 3mg, and SEK76,046.00 for 21 capsules of 4mg. The drug is included in the reimbursement system as of 19 June. The full decision is available, in Swedish, here.
Aubagio gets limited reimbursement further to re-evaluation
Further to the requested additional submission from the manufacturer, the TLV has reconsidered its previous decision on multiple sclerosis (MS) drug Aubagio (teriflunomid; Genzyme, a subsidiary of Sanofi, France). Following the re–evaluation, the TLV has decided to allow Aubagio limited reimbursement when interferon beta preparations are unsuccessful or when treatment with interferon beta preparation is not an appropriate option. Aubagio forms, like Copaxone, an additional alternative to treatment with interferon beta. Aubagio has, at a lower price than Copaxone, a different mechanism of action and side effects than interferon beta preparations. Granting Aubagio limited reimbursement enables the introduction of a new treatment option for the patient group and at a lower price than Copaxone. Against this background, the TLV has determined that it is reasonable to reconsider its earlier decision. The PPP approved for the drug is SEK8,726.00 for 28 tablets of 14mg and SEK26,178.00 for 84 tablets of 14mg. The drug is included in the reimbursement system as of 20 June. The full decision is available, in Swedish, here.
TLV rejects application for reimbursement of Erivedge
Swiss firm Roche's Erivedge (vismodegib) has not been approved for reimbursement by the TLV for the treatment of advanced form of basal cell carcinoma (BCC). The TLV has estimated, in fact, that the cost of the treatment is too high in relation to the health benefits provided. Erivedge is intended to be used in the treatment of adult patients with symptomatic metastatic BCC, or with locally advanced BCC not suitable for treatment with surgery or radiation. Erivedge demonstrated clinical benefits for patients with locally advanced BCC and for patients with symptomatic metastatic BCC in a small clinical trial in which there was no control group. However, the TLV notes that data showing the effect on survival are missing. The company has submitted a cost-benefit analysis that is based on a combination of data from the clinical study and data from the Swedish BCC register. Therefore, the TLV does not believe that the company has provided sufficient data to support the advantages that the company emphasises. Furthermore, the TLV estimates the cost of patient benefits from treatment with Erivedge is high. Erivedge is, therefore, not considered by the agency a cost-effective treatment at the current price. For these reasons, the TLV has decided to not recommend Erivedge for inclusion in the reimbursement system. The full decision in available, in Swedish, here.
Outlook and implications
The positive decisions issued by the TLV represent encouraging news for the applicants, which gain access to the Swedish reimbursement system. Access to reimbursement is essential for pharmaceutical companies to boost their sales in the country. In fact, the inclusion of a medicine in the reimbursement list is likely to increase patients' access to the treatment, with positive repercussions for the company in terms of sales.
In particular, Genzyme has secured reimbursement further to the appeal presented against the negative TLV decision issued in May and has requested the TLV to reconsider its previous decision (see Sweden: 26 May 2014: TLV rejects Sanofi's application for inclusion of Aubagio in national reimbursement list). The reassessment has enabled Aubagio to be reimbursed for the same indications as Copaxone.
The TLV decision, conversely, represents a setback for Roche, as its application for reimbursement for its BCC drug has been rejected. This is expected to limit significantly Erivedge's access to the BCC segment of the Swedish market.