Table 1.

National Health Systems’ criteria for reimbursement.

	Reimbursement level			Disease			Length	BMD				Fractures				BP trial		Reimbursement criteria	Additional comments
	Reimbursement Level (% covered by public payer)	Reimbursed under Govt. Program	Review Timing	PMOP Women	Male	GIOP	months	n/a	⩽−2.5	⩽−3.0	⩽−3.5	n/a	⩾1	⩾2	⩾3	n/a	12+ months
ARGENTINA	not reimbursed nationally	no	no specific timeline as no social security	yes	yes	yes		x				x				x		PMO Women and Male reimbursed. GIOP and 24 Month, not yet	In Argentina, the procedure is similar to Colombia, every patient is in a ‘obra social’ or ‘medicina prepaga’ system. If the reimbursement has been denied. The patients need to go to a court to ask them to force their ‘obra social’ to reimburse Forteo. in Argentina, when they go to court they do not get the reimbursement for the total 18 month treatment. It is valid for only 3 months. It is also approved for PMW and men
AUSTRALIA	100%			yes	yes	no	18			x				x			x	Initial treatment, as the sole PBS-subsidized agent, by a specialist or consultant physician, for severe, established osteoporosis in a patient with a very high risk of fracture who: a) has a BMD T-score of −3.0 or less, and b) has had two or more fractures due to minimal trauma, and c) has experienced at least one symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses or d) treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use. Details of the contraindication or intolerance must be provided at the time of application. Link to PBS site: http://www.pbs.gov.au/medicine/item/9411H
BRAZIL	not reimbursed nationally	YES (9 STATES HAVE A PROTOCOL) & NO (FEDERAL)									x	x						AT LEAST 1 FRACTURE: Vertebral or nonvertebral based on Rx or Dexa Exam BMD Less than −4.0 based on DEXA Exam (patient usually over 70) BP failure required (patients still losing BMD while on BP)
CANADA	not reimbursed nationally	Coverage on government program in Quebec. Otherwise coverage is on private insurance programs only							x	select. pop.			x				x	Physician should fill out forms detailing BMD and X ray results of previous fractures. patient has reached a low enough T-score, used BP for a period of time( e.g.: 1–2 years) and has fracture on it Reimbursed in Quebec: Forteo is reimbursed with private insurances. Criteria for coverage varies. Teriparatide is newly reimbursed for a very select patient population with AFF or ONJ, under the Ontario Public Drug Program through the Exceptional Access Program. Up to two years of teriparatide treatment is reimbursed for patients who: 1. Require teriparatide for treatment of osteoporosis, according to the prescribing physician AND 2. Are at least 65 years old and mobile AND3. Are at high risk of fragility fracture (prior fragility fracture and BMD T-score <−3.0) AND 4. Have ONJ or AFF believed to be due to use of an AR agent. (Note: Teriparatide is prescribed on the basis of adverse events [ONJ, AFF] sustained on previous ARs and on the basis of the failure or intolerance to previous osteoporosis therapy. Teriparatide is used as a treatment to address underlying osteoporosis, but is not to be used to treat ONJ or AFFs.)	In Canada, Forteo is reimbursed with private insurances. Criteria for coverage varies. For the public market, Forteo is not listed on any provincial or territorial except Quebec. Quebec- For treatment of severe OP in PMO: o Whose OP fxs are documented by a t-score of −3.0 or less: AND • Who have shown an inadequate response to continued taking of a BP (or raloxifene, if a BP is contraindicated), that is, who have shown the following characteristics: • A new fragility fracture following continued taking of the antiresorptive therapy for at least 12 months; OR • Significant decrease in BMD, less than the t-score observed during pretreatment, despite continued taking of the antiresorptive therapy for at least 24 months. • The total duration of the authorization is 18 months
FRANCE	65%	yes	In France each drug is reviewed by the Transparency Commission every 5 years after the first decision for reimbursement.	yes	yes	yes	18	x						x		x		Women and men with established osteoporosis with at least 2 vertebral fractures. (The treatment by FORSTEO could consequently precede or follow a treatment by BP or by SERM). When Forsteo is initiating in second intent after a BP, a wash out period of unknown duration (between 6 and 12 months according the expert opinion) could be observed, due to the persistent effect of the BP. This wash out period could be less longer in case of a previous treatment by a SERM). Those criteria are more for PMW, Men, and GIOP ( since January 09)	GIOP: http://www.has-sante.fr/portail/upload/docs/application/pdf/2010-09/forsteo_ct_5572.pdf MEN: http://www.has-sante.fr/portail/upload/docs/application/pdf/2010-06/forsteo_ct_5200.pdf PMO: http://www.has-sante.fr/portail/jcms/c_854109/fr/forsteo
ITALY	100%	yes		yes	yes	yes	24						X [GIOP or T-score ⩽ -4.0]	X	x			New criteria (Nota 79) (2015): PMO, Males and GIOP: Forsteo is reimbursed as a First line treatment in these different cases: 1. New vertebral or femoral fracture despite being in treatment with other Nota 79 drug for 1 or more years 2. ⩾3 vertebral or femoral fracture 3. ⩾1 fracture + back or femoral T-score ⩽−4 4. Patient treated for more than a year with >5 mg dose per day of prednisone or (or equivalent) that report one or more fracture	GPs can only prescribe for refills only; reimbursement has to be renewed every 6 months. Unrestricted access has been granted to all regions for PMOP, male, and GIOP indications. The 24-month indication was approved nationally in June 2011. As of October 2011, 20/21 regions have changed reimbursement from 18 to 24 months. http://www.agenziafarmaco.gov.it/it/content/nota-79
JAPAN	100%			yes	no	no	24		x				x			x		Fully reimbursed based on the label. PI states that efficacy and safety in men has not been confirmed so use in men is not recommended. No description of GIOP in label. If doctors believe it is appropriate for these patients then they can use it and each local authority can determine if it is appropriate for reimbursement. There are no reimbursement guidelines.
SOUTH AFRICA	not reimbursed nationally			yes	yes	yes

AFF, atypical femoral fracture; AR, anti-resorptive; BMD, bone mineral density; BP, bisphosphonate; GIOP, glucocorticoid-induced osteoporosis; GP, general practitioner; ONJ, osteonecrosis of the jaw; OP, osteoporosis; PMOP/PMO, postmenopausal osteoporosis, PMW postmenopausal women; SERM, selective estrogen receptor modulator; TGA therapeutic goods administration.