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Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis


Background:
Drug manufacturers have developed “evergreening” strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs) on the healthcare system as a whole (“spillover effect”).

Methods and Findings:
We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. “Extra costs” were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1) all brand (i.e., initially patented) drugs, (2) all follow-on drugs, or (3) brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community.

Estimated “extra costs” over the study period were €15.9 (95% CI 15.5; 16.2) million for scenario 1, €14.4 (95% CI 14.1; 14.7) million for scenario 2, and €30.3 (95% CI 29.8; 30.8) million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover “extra cost” of €330,300 (95% CI 276,100; 383,800), whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100). Overall we estimated that the RDF resulted in “extra costs” of €503,600 (95% CI 444,500; 563,100).

Conclusions:
Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to increased overall healthcare costs by listing follow-on drugs in their RDF. Therefore, healthcare providers and policy makers should be aware of the impact of evergreening strategies.

Please see later in the article for the Editors' Summary


Vyšlo v časopise: Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis. PLoS Med 10(6): e32767. doi:10.1371/journal.pmed.1001460
Kategorie: Research Article
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1001460

Souhrn

Background:
Drug manufacturers have developed “evergreening” strategies to compete with generic medication after patent termination. These include marketing of slightly modified follow-on drugs. We aimed to estimate the financial impact of these drugs on overall healthcare costs and also to examine the impact of listing these drugs in hospital restrictive drug formularies (RDFs) on the healthcare system as a whole (“spillover effect”).

Methods and Findings:
We used hospital and community pharmacy invoice office data in the Swiss canton of Geneva to calculate utilisation of eight follow-on drugs in defined daily doses between 2000 and 2008. “Extra costs” were calculated for three different scenarios assuming replacement with the corresponding generic equivalent for prescriptions of (1) all brand (i.e., initially patented) drugs, (2) all follow-on drugs, or (3) brand and follow-on drugs. To examine the financial spillover effect we calculated a monthly follow-on drug market share in defined daily doses for medications prescribed by hospital physicians but dispensed in community pharmacies, in comparison to drugs prescribed by non-hospital physicians in the community.

Estimated “extra costs” over the study period were €15.9 (95% CI 15.5; 16.2) million for scenario 1, €14.4 (95% CI 14.1; 14.7) million for scenario 2, and €30.3 (95% CI 29.8; 30.8) million for scenario 3. The impact of strictly switching all patients using proton-pump inhibitors to esomeprazole at admission resulted in a spillover “extra cost” of €330,300 (95% CI 276,100; 383,800), whereas strictly switching to generic cetirizine resulted in savings of €7,700 (95% CI 4,100; 11,100). Overall we estimated that the RDF resulted in “extra costs” of €503,600 (95% CI 444,500; 563,100).

Conclusions:
Evergreening strategies have been successful in maintaining market share in Geneva, offsetting competition by generics and cost containment policies. Hospitals may be contributing to increased overall healthcare costs by listing follow-on drugs in their RDF. Therefore, healthcare providers and policy makers should be aware of the impact of evergreening strategies.

Please see later in the article for the Editors' Summary


Zdroje

1. AgranatII, CanerH (1999) Intellectual property and chirality of drugs. Drug Discov Today 4: 313–321.

2. MunosB (2009) Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Discov 8: 959–968.

3. TimonenJ, KarttunenP, BengtstromM, AhonenR (2009) The impact of generic substitution on the turnover and gross margin of pharmaceutical companies a survey 1 year and 5 years after the introduction of generic substitution in Finland. Health Policy 92: 116–123.

4. LexchinJ (2004) The effect of generic competition on the price of brand-name drugs. Health Policy 68: 47–54.

5. HughesDA, FernerRE (2010) New drugs for old: disinvestment and NICE. BMJ 340: c572.

6. SomogyiA, BochnerF, FosterD (2004) Inside the isomers: the tale of chiral switches. Australian Prescriber 27: 47–49.

7. HitchingsAW, BakerEH, KhongTK (2012) Making medicines evergreen. BMJ 345: e7941.

8. AgranatI, CanerH, CaldwellJ (2002) Putting chirality to work: the strategy of chiral switches. Nat Rev Drug Discov 1: 753–768.

9. AminT, KesselheimAS (2012) Secondary patenting of branded pharmaceuticals: a case study of how patents on two HIV drugs could be extended for decades. Health Aff (Millwood) 31: 2286–2294.

10. WangYR, PaulyMV (2005) Spillover effects of restrictive drug formularies: a case study of PacifiCare in California. Am J Manag Care 11: 24–26.

11. TordoffJM, MurphyJE, NorrisPT, ReithDM (2006) Use of centrally developed pharmacoeconomic assessments for local formulary decisions. Am J Health Syst Pharm 63: 1613–1618.

12. LjungbergC, LindbladAK, TullyMP (2007) Hospital doctors' views of factors influencing their prescribing. J Eval Clin Pract 13: 765–771.

13. The Federal Authorities of the Swiss Confederation (1994) Loi fédérale du 18 mars 1994 sur l'assurance-maladie (LAMal). RS 832.10. Available: http://www.admin.ch/ch/f/rs/c832_10.html. Accessed 30 April 2013.

14. MuijrersPE, GrolRP, SijbrandijJ, JanknegtR, KnottnerusJA (2005) Differences in prescribing between GPs: impact of the cooperation with pharmacists and impact of visits from pharmaceutical industry representatives. Fam Pract 22: 624–630.

15. WHO Collaborating Centre for Drug Statistics Methodology (2013) ATC/DDD index 2013 [database]. Available: http://www.whocc.no/atc_ddd_index/. Accessed 30 April 2013.

16. HelfensteinU (1996) Box-Jenkins modelling in medical research. Stat Methods Med Res 5: 3–22.

17. MorganOW, GriffithsC, MajeedA (2007) Interrupted time-series analysis of regulations to reduce paracetamol (acetaminophen) poisoning. PLoS Med 4: e105 doi:10.1371/journal.pmed.0040105

18. DylstP, SimoensS (2011) Does the market share of generic medicines influence the price level?: a European analysis. Pharmacoeconomics 29: 875–882.

19. PetersonLR (2005) Squeezing the antibiotic balloon: the impact of antimicrobial classes on emerging resistance. Clin Microbiol Infect 11(Suppl 5): 4–16.

20. SvenssonS, MansfieldPR (2004) Escitalopram: superior to citalopram or a chiral chimera? Psychother Psychosom 73: 10–16.

21. LandefeldCS, SteinmanMA (2009) The Neurontin legacy—marketing through misinformation and manipulation. N Engl J Med 360: 103–106.

22. VedulaSS, BeroL, SchererRW, DickersinK (2009) Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med 361: 1963–1971.

23. RichterJE, KahrilasPJ, JohansonJ, MatonP, BreiterJR, et al. (2001) Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: a randomized controlled trial. Am J Gastroenterol 96: 656–665.

24. SondergaardJ, VachK, KragstrupJ, AndersenM (2009) Impact of pharmaceutical representative visits on GPs' drug preferences. Fam Pract 26: 204–209.

25. FeelyJ, ChanR, McManusJ, O'SheaB (1999) The influence of hospital-based prescribers on prescribing in general practice. Pharmacoeconomics 16: 175–181.

26. AchermannR, SuterK, KronenbergA, GygerP, MuhlemannK, et al. (2011) Antibiotic use in adult outpatients in Switzerland in relation to regions, seasonality and point of care tests. Clin Microbiol Infect 17: 855–861.

27. GrantK, Al-AdhamiN, TordoffJ, LiveseyJ, BarbezatG, et al. (2006) Continuation of proton pump inhibitors from hospital to community. Pharm World Sci 28: 189–193.

28. GreeneJA, KesselheimAS (2011) Why do the same drugs look different? Pills, trade dress, and public health. N Engl J Med 365: 83–89.

29. WuEQ, YuAP, LauzonV, RamakrishnanK, MarynchenkoM, et al. (2011) Economic impact of therapeutic substitution of a brand selective serotonin reuptake inhibitor with an alternative generic selective serotonin reuptake inhibitor in patients with major depressive disorder. Ann Pharmacother 45: 441–451.

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Interné lekárstvo

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2013 Číslo 6
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