Patent expiry and costs for anticancer medicines for clinical use
Author byline as per print journal: Brian Godman, BSc, PhD; Claudia Wild, PhD; Alan Haycox, PhD
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Abstract:
Venkatesan S et al. have researched patent rights and pricing for (non-)tyrosine kinase inhibitors. It is not clear why the patent rights are so long and why prices of (non-)tyrosine kinase inhibitors can be high. These issues are discussed.
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Submitted: 15 March 2017; Revised: 15 March 2017; Accepted: 17 March 2017; Published online first: 31 March 2017
Drs Brian Godman, Claudia Wild and Alan Haycox review the paper by Venkatesan S et al. on the patent expiry of (non-)tyrosine kinase inhibitors (TKIs) [1].
Venkatesan S et al. are to be congratulated on publishing their interesting paper providing general insight into exclusivity and patent rights for the non-TKIs [1] used in the treatment of patients with cancer. The authors point out that the TKIs and some of the non-TKIs have long exclusive rights, which is a concern especially given some of their marginal or small health gains versus current standards. It is not clear why the patent lives are so long, and why there are such differences between Europe and the US. This may well be because of orphan status and other considerations; however, this information is not provided in their paper. The authors suggest that the long patent life may be due to the limited development time for these compounds; but this may also not necessarily be the case. In any event, as Venkatesan S et al. point out, there is increasing concern with the growing cost of new medicines [2], which would be enhanced by granting premium prices and long patent lives for new medicines. Countries, even high-income countries, are now struggling to fund all new valued medicines, which is not in the interest of any key stakeholder group [2, 3].
There has been a rise in the clinical approvals of kinase inhibitors. Consequently, this is one of the reasons why TKIs were singled out for special attention in this paper. However, the review suggests that all TKIs are equally beneficial, which is not the case. Having said this, imatinib is a concern to payers with sales enhanced by off-label use with initially high prices granted on the basis of orphan status [4]. Global sales were estimated at US$4.75 billion in 2014, making imatinib the 14th highest selling product worldwide that year [5]. The rationale for choosing the non-TKIs is also not fully explained. Nevertheless, the paper gives very good insight into their likely generic drug availability, which is crucial for health authorities given the low prices that could be achieved for some of these cancer medicines [6].
In the discussion, the authors make a number of good points regarding high prices for new cancer medicines. This is a key concern across countries, with prices of new cancer medicines rising up to tenfold during the past decade [7, 8]. Prices for new cancer medicines now average US$150,000 or more per year of life gained [9], often with marginal health gain versus current standards [10]. In their recent review, Grössmann and Wild [11] documented that out of 134 new indications approved for cancer medicines since 2009, no data was available for progression-free survival or overall survival in 27%. A positive impact was seen for median overall survival in 55.5%; however, only 16% showed a difference of more than three months [11], which is increasingly seen as a minimum for a new cancer medicine to be seen as an advance [2, 10]. These concerns with ever increasing prices led to calls by US oncologists to pharmaceutical companies to moderate their growth in the future [12, 13]. High prices are also a major concern to lower- and middle-income countries, which currently account for more than 70% of cancer mortality [14]. Increasing prices of new cancer medicines are also threatening the sustainability of universal health care in those countries that provide this given ever-growing prevalence rates for cancer [7, 15]. This is leading to calls that cancer should no longer be singled out for special attention as this has been exploited [16].
It is estimated by some authors that the cost of bringing a new cancer medicine to the market is lower than US$100 million [13], and that prices of generic bortezomib, dasatinib, everolimus and gefitinib could potentially be as low as 1% of the current selling price [6]. This justifies calls for price moderation for new cancer medicines, as well as initiatives to make generics of valued cancer medicines available as early as possible with the cost of cancer medicines now accounting for an ever increasing proportion of the total costs of cancer care [7]. In the meantime, health authorities need to critically rethink how new cancer medicines should be valued, especially given concerns with surrogate markers [2, 10, 17]. Payers and providers also need to increasingly collaborate before product launch to agree on the likely patient populations that will receive the most benefits from the new cancer medicines in order to limit their budget impact [18], and keep to this, as well as seek extensive discounts through risk-sharing arrangements [2, 19].
Overall, the paper by Venkatesan S et al. gives good insight into likely generic drug availability of key cancer medicines, which is crucial for health authorities given the potentially low prices that could be achieved [6]. The paper also highlights the need for increased transparency in relation to development times and patent periods, the need for new cancer medicines to be appraised similarly to all other medicines for pricing and reimbursement evaluations, and not singled out for special status, as well as greater transparency in pricing and reimbursement evaluations. The latter gives increasing concerns with high prices for new cancer medicines coupled with the low cost of goods of some [6, 13]. Finally, the observation that the development time for these (non-)TKIs is rather short should be investigated further through researching the actual timescales for phases I to III trials and earlier of the TKIs.
Competing interests: None.
Provenance and peer review: Commissioned; internally peer reviewed.
Authors
Brian Godman1,2,3, BSc, PhD
Claudia Wild4, PhD
Alan Haycox3, PhD
1Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, G4 0RE Glasgow, UK
2Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital Huddinge, SE-14186 Stockholm, Sweden
3Health Economics Centre, University of Liverpool Management School, University of Liverpool, Chatham Street, L69 7ZH Liverpool, UK
4Ludwig Boltzmann Institute of Health Technology Assessment, 7/20 Garnisongasse, AT-1090 Vienna, Austria
References
1. Venkatesan S, Lamfers M, Leenstra S, Vulto AG. Overview of the patent expiry of (non-)tyrosine kinase inhibitors approved for clinical use in the EU and the US. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(2):89-96. doi:10.5639/gabij.2017.0602.016
2. European Parliament. Godman B, Oortwijn W, de Waure C, Mosca I, Puggina A, Specchia ML, et al. Links between pharmaceutical R&D models and access to affordable medicines. A study for the ENVI Committee [homepage on the Internet]. [cited 2017 Mar 15]. Available from: http://www.europarl.europa.eu/RegData/etudes/STUD/2016/587321/IPOL_STU(2016)587321_EN.pdf
3. Malmström RE, Godman BB, Diogene E, Baumgärtel C, Bennie M, Bishop I, et al. Dabigatran – a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs. Front Pharmacol. 2013;4:39.
4. Kesselheim AS, Myers JA, Solomon DH, Winkel-mayer WC, Levin R, Avorn J. The prevalence and cost of unapproved uses of top-selling orphan drugs. PLoS One. 2012;7(2):e31894.
5. Top 50 pharmaceutical products by global sales. PMLiVE.
6. Hill A, Redd C, Gotham D, Erbacher I, Meldrum J, Harada R. Estimated generic prices of cancer medicines deemed cost-ineffective in England: a cost estimation analysis. BMJ Open. 2017;7(1):e011965.
7. Kelly RJ, Smith TJ. Delivering maximum clinical benefit at an affordable price: engaging stakeholders in cancer care. Lancet Oncol. 2014;15(3):e112-8.
8. Bach PB. Reforming the payment system for medical oncology. JAMA. 2013;310(3):261-2.
9. Howard DH, Bach PB, Berndt ER, Conti RM. Pricing in the market for anticancer drugs. J Econ Perspect. 2015;29(1):139-62.
10. Kantarjian HM, Fojo T, Mathisen M, Zwelling LA. Cancer drugs in the United States: Justum Pretium–the just price. J Clin Oncol. 2013;31(28):3600-4.
11. Grössmann N, Wild C. Between January 2009 and April 2016, 134 novel anticancer therapies were approved: what is the level of knowledge concerning the clinical benefit at the time of approval? ESMO Open. 2017;1:e000125. doi:10.1136/esmoopen-2016-000125
12. Tefferi A, Kantarjian H, Rajkumar SV, Baker LH, Abkowitz JL, Adamson JW, et al. In support of a patient-driven initiative and petition to lower the high price of cancer drugs. Mayo Clin Proc. 2015;90(8):996-1000.
13. Experts in Chronic Myeloid Leukemia. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood. 2013;121(22):4439-42.
14. World Health Organization. Hoen Et. Access to cancer treatment. A study of medicine pricing issues with recommendations for improving access to cancer medication [homepage on the Internet]. [cited 2017 Mar 15]. Available from: http://apps.who.int/medicinedocs/documents/s21758en/s21758en.pdf
15. Ghinea N, Kerridge I, Lipworth W. If we don’t talk about value, cancer drugs will become terminal for health systems. The Conversation. 26 July 2015.
16. Haycox A. Why cancer? Pharmacoeconomics. 2016;34(7):625-7.
17. Wild C, Grössmann N, Bonanno PV, Bucsics A, Furst J, Garuoliene K, et al. Utilisation of the ESMO-MCBS in practice of HTA. Ann Oncol. 2016;27(11):2134-6.
18. Matusewicz W, Godman B, Pedersen HB, Fürst J, Gulbinovic J, Mack A, et al. Improving the managed introduction of new medicines: sharing experiences to aid authorities across Europe. Expert Rev Pharmacoecon Outcomes Res. 2015;15(5):755-8.
19. Ferrario A, Kanavos P. Managed entry agreements for pharmaceuticals: the European experience. EMiNet, Brussels, Belgium. LSE Research Online. 2013.
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Author for correspondence: Brian Godman, BSc, PhD, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, G4 0RE Glasgow, UK; Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital Huddinge, SE-14186 Stockholm, Sweden
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Disclosure of Conflict of Interest Statement is available upon request.
Copyright © 2017 Pro Pharma Communications International
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Source URL: https://gabi-journal.net/patent-expiry-and-costs-for-anticancer-medicines-for-clinical-use.html
Patent expiry and costs for anticancer medicines for clinical use
Author byline as per print journal: Brian Godman, BSc, PhD; Claudia Wild, PhD; Alan Haycox, PhD
Abstract:
Venkatesan S et al. have researched patent rights and pricing for (non-)tyrosine kinase inhibitors. It is not clear why the patent rights are so long and why prices of (non-)tyrosine kinase inhibitors can be high. These issues are discussed.
Submitted: 15 March 2017; Revised: 15 March 2017; Accepted: 17 March 2017; Published online first: 31 March 2017
Drs Brian Godman, Claudia Wild and Alan Haycox review the paper by Venkatesan S et al. on the patent expiry of (non-)tyrosine kinase inhibitors (TKIs) [1].
Venkatesan S et al. are to be congratulated on publishing their interesting paper providing general insight into exclusivity and patent rights for the non-TKIs [1] used in the treatment of patients with cancer. The authors point out that the TKIs and some of the non-TKIs have long exclusive rights, which is a concern especially given some of their marginal or small health gains versus current standards. It is not clear why the patent lives are so long, and why there are such differences between Europe and the US. This may well be because of orphan status and other considerations; however, this information is not provided in their paper. The authors suggest that the long patent life may be due to the limited development time for these compounds; but this may also not necessarily be the case. In any event, as Venkatesan S et al. point out, there is increasing concern with the growing cost of new medicines [2], which would be enhanced by granting premium prices and long patent lives for new medicines. Countries, even high-income countries, are now struggling to fund all new valued medicines, which is not in the interest of any key stakeholder group [2, 3].
There has been a rise in the clinical approvals of kinase inhibitors. Consequently, this is one of the reasons why TKIs were singled out for special attention in this paper. However, the review suggests that all TKIs are equally beneficial, which is not the case. Having said this, imatinib is a concern to payers with sales enhanced by off-label use with initially high prices granted on the basis of orphan status [4]. Global sales were estimated at US$4.75 billion in 2014, making imatinib the 14th highest selling product worldwide that year [5]. The rationale for choosing the non-TKIs is also not fully explained. Nevertheless, the paper gives very good insight into their likely generic drug availability, which is crucial for health authorities given the low prices that could be achieved for some of these cancer medicines [6].
In the discussion, the authors make a number of good points regarding high prices for new cancer medicines. This is a key concern across countries, with prices of new cancer medicines rising up to tenfold during the past decade [7, 8]. Prices for new cancer medicines now average US$150,000 or more per year of life gained [9], often with marginal health gain versus current standards [10]. In their recent review, Grössmann and Wild [11] documented that out of 134 new indications approved for cancer medicines since 2009, no data was available for progression-free survival or overall survival in 27%. A positive impact was seen for median overall survival in 55.5%; however, only 16% showed a difference of more than three months [11], which is increasingly seen as a minimum for a new cancer medicine to be seen as an advance [2, 10]. These concerns with ever increasing prices led to calls by US oncologists to pharmaceutical companies to moderate their growth in the future [12, 13]. High prices are also a major concern to lower- and middle-income countries, which currently account for more than 70% of cancer mortality [14]. Increasing prices of new cancer medicines are also threatening the sustainability of universal health care in those countries that provide this given ever-growing prevalence rates for cancer [7, 15]. This is leading to calls that cancer should no longer be singled out for special attention as this has been exploited [16].
It is estimated by some authors that the cost of bringing a new cancer medicine to the market is lower than US$100 million [13], and that prices of generic bortezomib, dasatinib, everolimus and gefitinib could potentially be as low as 1% of the current selling price [6]. This justifies calls for price moderation for new cancer medicines, as well as initiatives to make generics of valued cancer medicines available as early as possible with the cost of cancer medicines now accounting for an ever increasing proportion of the total costs of cancer care [7]. In the meantime, health authorities need to critically rethink how new cancer medicines should be valued, especially given concerns with surrogate markers [2, 10, 17]. Payers and providers also need to increasingly collaborate before product launch to agree on the likely patient populations that will receive the most benefits from the new cancer medicines in order to limit their budget impact [18], and keep to this, as well as seek extensive discounts through risk-sharing arrangements [2, 19].
Overall, the paper by Venkatesan S et al. gives good insight into likely generic drug availability of key cancer medicines, which is crucial for health authorities given the potentially low prices that could be achieved [6]. The paper also highlights the need for increased transparency in relation to development times and patent periods, the need for new cancer medicines to be appraised similarly to all other medicines for pricing and reimbursement evaluations, and not singled out for special status, as well as greater transparency in pricing and reimbursement evaluations. The latter gives increasing concerns with high prices for new cancer medicines coupled with the low cost of goods of some [6, 13]. Finally, the observation that the development time for these (non-)TKIs is rather short should be investigated further through researching the actual timescales for phases I to III trials and earlier of the TKIs.
Competing interests: None.
Provenance and peer review: Commissioned; internally peer reviewed.
Authors
Brian Godman1,2,3, BSc, PhD
Claudia Wild4, PhD
Alan Haycox3, PhD
1Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, G4 0RE Glasgow, UK
2Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital Huddinge, SE-14186 Stockholm, Sweden
3Health Economics Centre, University of Liverpool Management School, University of Liverpool, Chatham Street, L69 7ZH Liverpool, UK
4Ludwig Boltzmann Institute of Health Technology Assessment, 7/20 Garnisongasse, AT-1090 Vienna, Austria
References
1. Venkatesan S, Lamfers M, Leenstra S, Vulto AG. Overview of the patent expiry of (non-)tyrosine kinase inhibitors approved for clinical use in the EU and the US. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(2):89-96. doi:10.5639/gabij.2017.0602.016
2. European Parliament. Godman B, Oortwijn W, de Waure C, Mosca I, Puggina A, Specchia ML, et al. Links between pharmaceutical R&D models and access to affordable medicines. A study for the ENVI Committee [homepage on the Internet]. [cited 2017 Mar 15]. Available from: http://www.europarl.europa.eu/RegData/etudes/STUD/2016/587321/IPOL_STU(2016)587321_EN.pdf
3. Malmström RE, Godman BB, Diogene E, Baumgärtel C, Bennie M, Bishop I, et al. Dabigatran – a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs. Front Pharmacol. 2013;4:39.
4. Kesselheim AS, Myers JA, Solomon DH, Winkel-mayer WC, Levin R, Avorn J. The prevalence and cost of unapproved uses of top-selling orphan drugs. PLoS One. 2012;7(2):e31894.
5. Top 50 pharmaceutical products by global sales. PMLiVE.
6. Hill A, Redd C, Gotham D, Erbacher I, Meldrum J, Harada R. Estimated generic prices of cancer medicines deemed cost-ineffective in England: a cost estimation analysis. BMJ Open. 2017;7(1):e011965.
7. Kelly RJ, Smith TJ. Delivering maximum clinical benefit at an affordable price: engaging stakeholders in cancer care. Lancet Oncol. 2014;15(3):e112-8.
8. Bach PB. Reforming the payment system for medical oncology. JAMA. 2013;310(3):261-2.
9. Howard DH, Bach PB, Berndt ER, Conti RM. Pricing in the market for anticancer drugs. J Econ Perspect. 2015;29(1):139-62.
10. Kantarjian HM, Fojo T, Mathisen M, Zwelling LA. Cancer drugs in the United States: Justum Pretium–the just price. J Clin Oncol. 2013;31(28):3600-4.
11. Grössmann N, Wild C. Between January 2009 and April 2016, 134 novel anticancer therapies were approved: what is the level of knowledge concerning the clinical benefit at the time of approval? ESMO Open. 2017;1:e000125. doi:10.1136/esmoopen-2016-000125
12. Tefferi A, Kantarjian H, Rajkumar SV, Baker LH, Abkowitz JL, Adamson JW, et al. In support of a patient-driven initiative and petition to lower the high price of cancer drugs. Mayo Clin Proc. 2015;90(8):996-1000.
13. Experts in Chronic Myeloid Leukemia. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood. 2013;121(22):4439-42.
14. World Health Organization. Hoen Et. Access to cancer treatment. A study of medicine pricing issues with recommendations for improving access to cancer medication [homepage on the Internet]. [cited 2017 Mar 15]. Available from: http://apps.who.int/medicinedocs/documents/s21758en/s21758en.pdf
15. Ghinea N, Kerridge I, Lipworth W. If we don’t talk about value, cancer drugs will become terminal for health systems. The Conversation. 26 July 2015.
16. Haycox A. Why cancer? Pharmacoeconomics. 2016;34(7):625-7.
17. Wild C, Grössmann N, Bonanno PV, Bucsics A, Furst J, Garuoliene K, et al. Utilisation of the ESMO-MCBS in practice of HTA. Ann Oncol. 2016;27(11):2134-6.
18. Matusewicz W, Godman B, Pedersen HB, Fürst J, Gulbinovic J, Mack A, et al. Improving the managed introduction of new medicines: sharing experiences to aid authorities across Europe. Expert Rev Pharmacoecon Outcomes Res. 2015;15(5):755-8.
19. Ferrario A, Kanavos P. Managed entry agreements for pharmaceuticals: the European experience. EMiNet, Brussels, Belgium. LSE Research Online. 2013.
Author for correspondence: Brian Godman, BSc, PhD, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, G4 0RE Glasgow, UK; Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital Huddinge, SE-14186 Stockholm, Sweden
Disclosure of Conflict of Interest Statement is available upon request.
Copyright © 2017 Pro Pharma Communications International
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Source URL: https://gabi-journal.net/patent-expiry-and-costs-for-anticancer-medicines-for-clinical-use.html