Innovative public purchase

Innovative public purchase

During The last two months HiTT has been working in 2 different projects of innovative public purchase, and last week we finally have presented them to the regional health service call. The Innovative public purchase is a tool used by the EU to foster the innovation purchase from the public institutions. It is a contract that public institution offers, to satisfy a present need through an innovative solution. The basis is the purchase through the service demand rather than from the solution supply. Both projects try to redefine the relationship between professionals and patients; the two projects are focused on the information system for the patient profile determination. That is to say, the personalization of the health through the phenotypes analysis and the revealed behaviour, not through the genomic studies. We hope we can continue along these...
Spain’s (and Portugal’s) Market Access – update Oct16

Spain’s (and Portugal’s) Market Access – update Oct16

About 60.000 patients treated from HCV infection. Read more. MOH released data on drug access. 59.000 patients treated this year (52.000 F2-F4). Curation rete is at 97% Targeted patients account for 95.000 patients in Spain. The EU Socialist party presents a proposal on innovation at the EU Parliament, and then presents it to the Spanish parliament, where they get support. Read more. ‘…harmonizing the criteria for pricing and reimbursement to take into account the level of innovation and analysis of economic and social profitability, and establish a European classification of the added value of medicines.’ Spanish AEMPS accepts biosimilar indication extrapolation. Read more. Sol Ruiz, Officer from the AEMPS stated last week after the Spanish Rheumatoid Association meeting that “It is possible to extrapolate indications” and referred to the same arguments used to pass the extrapolation of indications of biosimilars” Portuguese Hospitals to be imposed Biosimilar quotas. Read more. Hospitals Portuguese National Health Service (NHS) will have to reach a minimum quota of 20 percent for biosimilars in 2017, as reported by the National Authority of Medicines and Portuguese Health Products (Infarmed) through a statement . In the policy note issued by the Portuguese news agency, ensure that the objective of this measure is to “increase the savings potential of these drugs, optimizing available resources to facilitate the financing of new innovations.”...
Spain’s Market Access – update Sep16

Spain’s Market Access – update Sep16

POLICY Private health expenditure increases 23%: After cuts in public spending, private expenditure has increased by 23%. Read more. Hospital expenditure is reduced by -3.1% in July. For the 7th month in a row, hospital expenditure is reduced. Read more. …while prescription drug expenditure is further increased by 10%: Interanual drug expenditure has expanded +10% according to data from MoH. Read more.   DRUGS MOH: diagnostic drugs ‘can and should go’ to hospital pharmacy. In a recent meeting at Universidad de Santander (UIMP), an officer from MoH declared that they are hoping to shift diagnostic drugs to hospital pharmacy, as this may induce further savings. Read more. Services in Community pharmacies being expanded. Progressive implementation of remunerated tests in community pharmacies, as part of public health programmes. Services are being paid by public insurers. Read more.   INDUSTRY Farmaindustria presented a programme for professionals and patients to improve adherence. They have been preparing with patients and specialists on solutions to improve patients adherence, a major concern for clinicians and payers. Read more Biosimilars Manufacturers request a comprehensive legislative package. After some years in the market, the Industry is demanding a clear regulation. Read more Andalucia’s tendering attracts 16 manufacturers. After their 9th tender for generic drugs, 16 manufacturers applied for the general tender organised by the Region. Read more Seven businesses closing down per day in the last 4 months. Impressive figures on industrial shutdown in the last months. Read more...
Spain’s Market Access update – Aug’16

Spain’s Market Access update – Aug’16

POLICY 70% of the Region’s debt is in Healthcare: total commercial debt to the regions their suppliers rose in May to 9.431 million euros, of which 6.609 million, ie 70%, corresponds to the health sector. Read the Official Ministry Report. Andalucía uses the Electronic prescription to avoid User Charges. As much as 312,000 people a month have avoided having to pay UC when withdrawing a drug. Read more. Valencia is proposing to introduce Therapeutic Equivalents, which beyond the formal definition, include drugs for the same disease with a similar mode of action. Physicians and academic societies are against them. Read more. INDUSTRY Bidafarma is the new wholesaler giant in Andalucía. Read more. Almirall deepens into dermatologic care. It has in-licenced a patent pro Psoriasis. Read the post. DRUGS: Valencia is proposing a network to evaluate and select drugs to be applied across the region. Read more Supreme Court obliges Andalusia to return the compulsory discounts made when naming drugs as Hospital Only. Andalusia has been designating some drugs as HO, entailing them to a compulsory discount. The Supreme Court has ruled that the Region cannot decide which drugs are HO on their own and therefore obliges them to return those discounts to companies. Drug expenditure rose in June16 5’18% more than the previous period last year. New reference groups created 26 new RG have been created, 6 less than the expected There is a RG for vaccines for Varicella, that have been very controversial in the last 2 years. 126 M€ is the estimated impact of these groups. DEVICES: Spanish Agency for Medicines and Health Products (AEMPS) puts in...
Genetic Therapy and the Industrial Uncertainties

Genetic Therapy and the Industrial Uncertainties

Last week, EMA approved Strimvelis for the treatment of severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID). It is the second genetic therapy approved by EMA after Glybera was cleared in 2012. The usual discussion goes around rarity, investment and pricing, which have been set at very high levels with a few unknowns on efficacy and long term safety. Let alone the price and the efficiency, the social need and the safety concerns, I would like to raise a parallel question, from the industrial and economic perspective. If the EU has invested so much in genetic research, is still investing in transferring technologies that will enable more gene therapy, shouldn’t we have some more clarity on how we’re going to pay for this? The contradiction is obvious: why accumulate technologies for which we are never going to pay for? Or alternatively, if the strategy is to generate competition to break monopolies, will these companies resist the desert valley? If there is no industrial reward, how are we going to raise money to fund RnD? I guess it is time to discuss about how to proceed with this. The uncertainties are great, the clinical risks unknown, the future developments an unrevealed promise, but yet we should discuss how to look after this emerging industry, or have some kind of mid term...